Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-03-17 @ 9:04 AM
Study NCT ID:
NCT00286468
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2006-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520853', 'term': 'alogliptin'}, {'id': 'D005905', 'term': 'Glyburide'}], 'ancestors': [{'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '800-778-2860', 'title': 'Sr. VP, Clinical Science', 'organization': 'Takeda Global Research and Development Center, Inc.'}, 'certainAgreement': {'otherDetails': 'No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.', 'otherNumAtRisk': 99, 'otherNumAffected': 23, 'seriousNumAtRisk': 99, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.', 'otherNumAtRisk': 203, 'otherNumAffected': 49, 'seriousNumAtRisk': 203, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.', 'otherNumAtRisk': 198, 'otherNumAffected': 64, 'seriousNumAtRisk': 198, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Osteomyelitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'electrocardiogram change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Facial palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.084', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.058', 'groupId': 'OG001'}, {'value': '-0.52', 'spread': '0.058', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '-0.19', 'pValueComment': 'A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'groupDescription': 'Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \\>=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per-protocol analysis set assuming SD=0.8%, 2-sided \\>0.05 significance level, and \\>=80% of subjects meeting per protocol criteria.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for glycosylated hemoglobin as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '-0.33', 'pValueComment': 'A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'groupDescription': 'Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \\>=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \\>0.05 significance level and \\>=80% of subjects meeting per-protocol criteria.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 4).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.028', 'groupId': 'OG001'}, {'value': '-0.46', 'spread': '0.029', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '-0.13', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '-0.18', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at week 4 due to unavailable prior value to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.057', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '-0.65', 'spread': '0.040', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '-0.26', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '-0.33', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.068', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '-0.69', 'spread': '0.047', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.25', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '-0.36', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.050', 'groupId': 'OG001'}, {'value': '-0.66', 'spread': '0.051', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '-0.19', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '-0.33', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.077', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.053', 'groupId': 'OG001'}, {'value': '-0.60', 'spread': '0.054', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '-0.17', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '-0.34', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 1).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '-11.8', 'spread': '2.51', 'groupId': 'OG001'}, {'value': '-19.0', 'spread': '2.53', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.1', 'ciLowerLimit': '-20.8', 'ciUpperLimit': '-3.4', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.3', 'ciLowerLimit': '-28.0', 'ciUpperLimit': '-10.6', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 1.', 'description': 'The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 2).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '-16.7', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-21.8', 'spread': '2.23', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.9', 'ciLowerLimit': '-22.5', 'ciUpperLimit': '-7.2', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.0', 'ciLowerLimit': '-27.7', 'ciUpperLimit': '-12.4', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 2.', 'description': 'The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 4).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.7', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '-14.6', 'spread': '2.42', 'groupId': 'OG001'}, {'value': '-21.1', 'spread': '2.43', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.9', 'ciLowerLimit': '-19.3', 'ciUpperLimit': '-2.6', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.4', 'ciLowerLimit': '-25.8', 'ciUpperLimit': '-9.1', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '3.55', 'groupId': 'OG000'}, {'value': '-19.9', 'spread': '2.46', 'groupId': 'OG001'}, {'value': '-18.6', 'spread': '2.47', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.7', 'ciLowerLimit': '-25.2', 'ciUpperLimit': '-8.2', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.4', 'ciLowerLimit': '-23.9', 'ciUpperLimit': '-6.9', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '3.79', 'groupId': 'OG000'}, {'value': '-13.5', 'spread': '2.64', 'groupId': 'OG001'}, {'value': '-15.0', 'spread': '2.66', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.1', 'ciLowerLimit': '-19.2', 'ciUpperLimit': '-1.0', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.7', 'ciLowerLimit': '-20.8', 'ciUpperLimit': '-2.5', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.1', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '2.81', 'groupId': 'OG001'}, {'value': '-13.0', 'spread': '2.83', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.701', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-11.6', 'ciUpperLimit': '7.8', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.228', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.0', 'ciLowerLimit': '-15.7', 'ciUpperLimit': '3.7', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '4.41', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '3.08', 'groupId': 'OG001'}, {'value': '-13.6', 'spread': '3.10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.0', 'ciLowerLimit': '-19.6', 'ciUpperLimit': '1.6', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.3', 'ciLowerLimit': '-23.9', 'ciUpperLimit': '-2.7', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 26).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '3.33', 'groupId': 'OG001'}, {'value': '-8.4', 'spread': '3.36', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.241', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.8', 'ciLowerLimit': '-18.3', 'ciUpperLimit': '4.6', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.072', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.5', 'ciLowerLimit': '-22.0', 'ciUpperLimit': '0.9', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.338', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.775', 'ciLowerLimit': '0.460', 'ciUpperLimit': '1.306', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.521', 'ciLowerLimit': '0.306', 'ciUpperLimit': '0.887', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 Weeks.', 'description': 'The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set) and have at least 1 post-baseline measurement for fasting plasma glucose.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Rescue.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.374', 'ciLowerLimit': '0.194', 'ciUpperLimit': '0.720', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.372', 'ciLowerLimit': '0.193', 'ciUpperLimit': '0.718', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 Weeks.', 'description': 'The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin (Week 4).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '1.84', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '1.84', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.923', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '6.7', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.259', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.7', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '10.1', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin (Week 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.2', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '1.81', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.81', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.916', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '5.9', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.305', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '9.5', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '1.73', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.953', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '5.8', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.957', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '5.8', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin (Week 16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.81', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '1.81', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.908', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '6.6', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.826', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '7.0', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.84', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '1.84', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.894', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '6.8', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.432', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '8.9', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin (Week 26).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '1.81', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '1.81', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.548', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-8.1', 'ciUpperLimit': '4.3', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.986', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '6.2', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin (Week 4).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.62', 'spread': '1.273', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.879', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '0.877', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.415', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '-1.78', 'ciUpperLimit': '4.30', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.332', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '-1.54', 'ciUpperLimit': '4.55', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of insulin collected at week 4 and insulin collected at baseline.', 'unitOfMeasure': 'mcIU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. 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Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '1.464', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '1.009', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '1.010', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.448', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '-2.14', 'ciUpperLimit': '4.85', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.568', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '-2.48', 'ciUpperLimit': '4.52', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of insulin collected at week 12 and insulin collected at baseline.', 'unitOfMeasure': 'mcIU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin (Week 16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.21', 'spread': '1.368', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '0.943', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '0.944', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.077', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.95', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '6.22', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.303', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '4.99', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of insulin collected at week 16 and insulin collected at baseline.', 'unitOfMeasure': 'mcIU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. 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Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0172', 'groupId': 'OG000'}, {'value': '-0.037', 'spread': '0.0119', 'groupId': 'OG001'}, {'value': '-0.041', 'spread': '0.0119', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.062', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.039', 'ciLowerLimit': '-0.080', 'ciUpperLimit': '0.002', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.041', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.043', 'ciLowerLimit': '-0.084', 'ciUpperLimit': '-0.002', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.0167', 'groupId': 'OG000'}, {'value': '-0.035', 'spread': '0.0116', 'groupId': 'OG001'}, {'value': '-0.036', 'spread': '0.0115', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.148', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.030', 'ciLowerLimit': '-0.069', 'ciUpperLimit': '0.010', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.135', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.031', 'ciLowerLimit': '-0.071', 'ciUpperLimit': '0.009', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 26).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.008', 'spread': '0.0161', 'groupId': 'OG000'}, {'value': '-0.034', 'spread': '0.0111', 'groupId': 'OG001'}, {'value': '-0.034', 'spread': '0.0111', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.177', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.026', 'ciLowerLimit': '-0.065', 'ciUpperLimit': '0.012', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.177', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.026', 'ciLowerLimit': '-0.065', 'ciUpperLimit': '0.012', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-peptide (Week 4).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.041', 'spread': '0.1355', 'groupId': 'OG000'}, {'value': '0.122', 'spread': '0.0932', 'groupId': 'OG001'}, {'value': '0.136', 'spread': '0.0930', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.324', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.162', 'ciLowerLimit': '-0.161', 'ciUpperLimit': '0.486', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.284', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.176', 'ciLowerLimit': '-0.147', 'ciUpperLimit': '0.500', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-peptide (Week 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.176', 'spread': '0.1138', 'groupId': 'OG000'}, {'value': '0.092', 'spread': '0.0786', 'groupId': 'OG001'}, {'value': '0.173', 'spread': '0.0785', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.268', 'ciLowerLimit': '-0.004', 'ciUpperLimit': '0.540', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.349', 'ciLowerLimit': '0.077', 'ciUpperLimit': '0.621', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-peptide (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.020', 'spread': '0.1155', 'groupId': 'OG000'}, {'value': '0.162', 'spread': '0.0797', 'groupId': 'OG001'}, {'value': '0.206', 'spread': '0.0801', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.182', 'ciLowerLimit': '-0.094', 'ciUpperLimit': '0.458', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.110', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.226', 'ciLowerLimit': '-0.051', 'ciUpperLimit': '0.502', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-peptide (Week 16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.007', 'spread': '0.1206', 'groupId': 'OG000'}, {'value': '0.222', 'spread': '0.0837', 'groupId': 'OG001'}, {'value': '0.153', 'spread': '0.0841', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.121', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.228', 'ciLowerLimit': '-0.060', 'ciUpperLimit': '0.517', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.280', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.159', 'ciLowerLimit': '-0.130', 'ciUpperLimit': '0.448', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-peptide (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.016', 'spread': '0.1275', 'groupId': 'OG000'}, {'value': '-0.001', 'spread': '0.0884', 'groupId': 'OG001'}, {'value': '0.122', 'spread': '0.0889', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.924', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.015', 'ciLowerLimit': '-0.290', 'ciUpperLimit': '0.320', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.376', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.138', 'ciLowerLimit': '-0.168', 'ciUpperLimit': '0.444', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-peptide (Week 26).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.215', 'spread': '0.1326', 'groupId': 'OG000'}, {'value': '-0.140', 'spread': '0.0920', 'groupId': 'OG001'}, {'value': '-0.153', 'spread': '0.0925', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.642', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.075', 'ciLowerLimit': '-0.242', 'ciUpperLimit': '0.393', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.698', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.063', 'ciLowerLimit': '-0.255', 'ciUpperLimit': '0.381', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.596', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.290', 'ciLowerLimit': '0.503', 'ciUpperLimit': '3.306', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}, {'pValue': '0.148', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.960', 'ciLowerLimit': '0.787', 'ciUpperLimit': '4.885', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.046', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.925', 'ciLowerLimit': '1.011', 'ciUpperLimit': '3.666', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.505', 'ciLowerLimit': '1.313', 'ciUpperLimit': '4.780', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.955', 'ciLowerLimit': '1.086', 'ciUpperLimit': '3.519', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.707', 'ciLowerLimit': '2.012', 'ciUpperLimit': '6.831', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.994', 'ciLowerLimit': '1.720', 'ciUpperLimit': '5.213', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.401', 'ciLowerLimit': '1.950', 'ciUpperLimit': '5.933', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.115', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.776', 'ciLowerLimit': '0.870', 'ciUpperLimit': '3.627', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. 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OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.986', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.991', 'ciLowerLimit': '0.365', 'ciUpperLimit': '2.689', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}, {'pValue': '0.131', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.050', 'ciLowerLimit': '0.808', 'ciUpperLimit': '5.203', 'pValueComment': 'no multiplicity adjustments', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.626', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'no multiplicity adjustments', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.', 'testedNonInferiority': False}, {'pValue': '0.178', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'no multiplicity adjustments', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight (Week 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.175', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.122', 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.124', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.16', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.17', 'ciUpperLimit': '1.02', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between Body Weight measured at week 8 and Body Weight measured at baseline.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.204', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.142', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.143', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.20', 'ciUpperLimit': '1.18', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.040', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.02', 'ciUpperLimit': '1.01', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between Body Weight measured at week 12 and Body Weight measured at baseline.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.264', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.184', 'groupId': 'OG001'}, {'value': '0.61', 'spread': '0.185', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.73', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.28', 'ciUpperLimit': '1.55', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between Body Weight measured at week 20 and Body Weight measured at baseline.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight (Week 26).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.277', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.193', 'groupId': 'OG001'}, {'value': '0.68', 'spread': '0.194', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.14', 'ciUpperLimit': '1.46', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.21', 'ciUpperLimit': '1.54', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'FG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'FG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '203'}, {'groupId': 'FG002', 'numSubjects': '198'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '153'}, {'groupId': 'FG002', 'numSubjects': '148'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Hyperglycemic Rescue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants enrolled at 125 investigative sites in Argentina, Australia, Brazil, Chile, Dominican Republic, Germany, Guatemala, India, Mexico, New Zealand, The Netherlands, Poland, South Africa, Spain, and the United States from 04 April 2006 to 20 June 2007.', 'preAssignmentDetails': 'Participants with a historical diagnosis of type 2 diabetes mellitus who were inadequately controlled while receiving a stable dose of glyburide monotherapy were enrolled in one of 3, once-daily (QD) treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}, {'value': '500', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'BG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'BG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '370', 'groupId': 'BG003'}]}]}, {'title': 'Between 65 and 74 years', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}]}, {'title': '≥75 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '261', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-01', 'studyFirstSubmitDate': '2006-02-01', 'resultsFirstSubmitDate': '2011-06-08', 'studyFirstSubmitQcDate': '2006-02-01', 'lastUpdatePostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-27', 'studyFirstPostDateStruct': {'date': '2006-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 1).', 'timeFrame': 'Baseline and Week 1.', 'description': 'The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 2).', 'timeFrame': 'Baseline and Week 2.', 'description': 'The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 26).', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.'}, {'measure': 'Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).', 'timeFrame': '26 Weeks.', 'description': 'The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.'}, {'measure': 'Number of Participants Requiring Rescue.', 'timeFrame': '26 Weeks.', 'description': 'The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.'}, {'measure': 'Change From Baseline in Fasting Proinsulin (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Proinsulin (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Proinsulin (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Proinsulin (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Proinsulin (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Proinsulin (Week 26).', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.'}, {'measure': 'Change From Baseline in Insulin (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of insulin collected at week 4 and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Insulin (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of insulin collected at week 8 and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Insulin (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of insulin collected at week 12 and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Insulin (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of insulin collected at week 16 and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Insulin (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of insulin collected at week 20 and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Insulin (Week 26).', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of insulin collected at week 26 and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 26).', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.'}, {'measure': 'Change From Baseline in C-peptide (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.'}, {'measure': 'Change From Baseline in C-peptide (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.'}, {'measure': 'Change From Baseline in C-peptide (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.'}, {'measure': 'Change From Baseline in C-peptide (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.'}, {'measure': 'Change From Baseline in C-peptide (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.'}, {'measure': 'Change From Baseline in C-peptide (Week 26).', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.'}, {'measure': 'Change From Baseline in Body Weight (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between Body Weight measured at week 8 and Body Weight measured at baseline.'}, {'measure': 'Change From Baseline in Body Weight (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between Body Weight measured at week 12 and Body Weight measured at baseline.'}, {'measure': 'Change From Baseline in Body Weight (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between Body Weight measured at week 20 and Body Weight measured at baseline.'}, {'measure': 'Change From Baseline in Body Weight (Week 26).', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glucose Metabolism Disorder', 'Dysmetabolic Syndrome', 'Type II Diabetes', 'Diabetes Mellitus', 'Lipoatrophic', 'Dyslipidemia', 'Drug Therapy'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '19125778', 'type': 'RESULT', 'citation': 'Pratley RE, Kipnes MS, Fleck PR, Wilson C, Mekki Q; Alogliptin Study 007 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab. 2009 Feb;11(2):167-76. doi: 10.1111/j.1463-1326.2008.01016.x.'}, {'pmid': '19793357', 'type': 'RESULT', 'citation': 'Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.', 'detailedDescription': 'There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.\n\nTakeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.\n\nThe aim of the current study is to evaluate the effectiveness of alogliptin in combination with a sulfonylurea in subjects who are inadequately controlled on a sulfonylurea alone. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Diagnosis of type 2 diabetes mellitus , currently treated with a sulfonylurea alone but experiencing inadequate glycemic control. Should have received the sulfonylurea monotherapy for at least the 3 months prior to Screening; has been on a stable sulfonylurea dose equivalent to at least 10 mg of glyburide (Exception: documented maximum tolerated dose equivalent to less than 10 mg but at least 5 mg glyburide) for at least 8 weeks.\n* No treatment with antidiabetic agents other than a sulfonylurea within the 3 months prior to Screening. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)\n* Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.\n* Fasting C-peptide concentration greater than or equal to 0.8 ng/mL. (If this screening criterion is not met, the subject still qualifies if C-peptide is greater than or equal to 1.5 ng/mL after a challenge test.).\n* Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive.\n* If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.\n* Systolic blood pressure less than or equal to180 mm Hg and diastolic pressure less than or equal to 110 mm Hg\n* Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to 10 g per dL for females\n* Alanine aminotransferase less than or equal to 3 time the upper limit of normal.\n* Serum creatinine ≤2.0 mg/dL (≤17 micromol/L)\n* Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid.\n* Neither pregnant nor lactating\n* Female subjects of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in the study.\n* Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.\n* No major illness or debility that in the investigator's opinion prohibits the subject from completing the study.\n* Able and willing to provide written informed consent\n\nExclusion Criteria\n\n* Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject may be rescreened within 1 week.\n* History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.)\n* History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.\n* History of treated diabetic gastric paresis.\n* New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study.\n* History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.\n* History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.\n* History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.\n* History of a psychiatric disorder that will affect the subject's ability to participate in the study.\n* History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.\n* History of alcohol or substance abuse within the 2 years prior to Screening.\n* Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening.\n* Prior treatment in an investigational study of alogliptin.\n* Excluded Medications and Treatments:\n\n * Treatment with antidiabetic agents other than study drug or glyburide is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures.\n * Treatment with weight-loss drugs, any investigational antidiabetics, Bosentan (used for the treatment of pulmonary hypertension), or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of- treatment/early termination procedures. Inhaled corticosteroids are allowed.\n * Subjects must not take any medications, including over-the-counter products, without first consulting with the investigator."}, 'identificationModule': {'nctId': 'NCT00286468', 'briefTitle': 'Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With a Sulfonylurea in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'SYR-322-SULF-007'}, 'secondaryIdInfos': [{'id': '2005-004667-36', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1113-8506', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alogliptin 12.5 mg QD', 'interventionNames': ['Drug: Alogliptin and glyburide']}, {'type': 'EXPERIMENTAL', 'label': 'Alogliptin 25 mg QD', 'interventionNames': ['Drug: Alogliptin and glyburide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Glyburide']}], 'interventions': [{'name': 'Alogliptin and glyburide', 'type': 'DRUG', 'otherNames': ['alogliptin', 'SYR110322', 'SYR-322'], 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.', 'armGroupLabels': ['Alogliptin 12.5 mg QD']}, {'name': 'Alogliptin and glyburide', 'type': 'DRUG', 'otherNames': ['alogliptin', 'SYR110322', 'SYR-322'], 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.', 'armGroupLabels': ['Alogliptin 25 mg QD']}, {'name': 'Glyburide', 'type': 'DRUG', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 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Cities', 'country': 'New Zealand'}, {'city': 'Multiple Cities', 'country': 'Peru'}, {'city': 'Multiple Cities', 'country': 'Poland'}, {'city': 'Multiple Cities', 'country': 'South Africa'}, {'city': 'Multiple Cities', 'country': 'United Kingdom'}], 'overallOfficials': [{'name': 'VP Biological Sciences', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}