Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-29 @ 7:19 AM
Study NCT ID:
NCT00664534
Status:
COMPLETED
Last Update Posted:
2011-12-13
First Post:
2008-04-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Saudi Arabia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D061268', 'term': 'Insulin Lispro'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture) 1, 2 or 3 injections plus OAMs', 'otherNumAtRisk': 169, 'otherNumAffected': 52, 'seriousNumAtRisk': 169, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Glargine', 'description': 'Glargine +/- 1, 2 or 3 injections of insulin lispro plus OAMs', 'otherNumAtRisk': 173, 'otherNumAffected': 53, 'seriousNumAtRisk': 173, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Viral pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}], 'seriousEvents': [{'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': "Castleman's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}, {'term': 'Transurethral prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '14.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'OG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}], 'classes': [{'categories': [{'measurements': [{'value': '7.55', 'groupId': 'OG000', 'lowerLimit': '7.27', 'upperLimit': '7.82'}, {'value': '7.40', 'groupId': 'OG001', 'lowerLimit': '7.15', 'upperLimit': '7.65'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.13', 'estimateComment': 'Least squares mean difference = (Premix insulin Lispro -Glargine)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority margin is defined as 0.4%. If the upper 95%CI for difference in LSMeans is below 0.4% then MIX arm will be declared noninferior to GLAR arm'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '48 weeks', 'description': 'Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population.', 'unitOfMeasure': 'percent glycosylated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PP Population=All participants who were randomized and met following criteria during study:\n\n* no violations of Inclusion/Exclusion Criteria\n* no early study discontinuation\n* compliant with treatment\n* received no other antihyperglycemic medication than allowed in Protocol, and have not been on systemic glucocorticoids for \\>14 consecutive days.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Using Each Possible Final Insulin Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'OG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}], 'classes': [{'title': 'MM before noon', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'LM before PM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'MM before noon+LM before PM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'LM before AM+MM before noon+LM before PM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'MM before AM+MM before noon+LM before PM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Glargine QD', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glargine QD+1 Lispro (noon or PM)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glargine QD+2 Lispro (noon and PM)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glargine QD+3 Lispro', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other (not specified)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Insulin Regimens:\n\nLispro: Mid-Mix (MM) before noon; Low-Mix (LM) before evening (PM); MM before noon+LM before PM; LM before morning (AM)+MM before noon + LM before PM; MM before AM +MM before noon+LM before PM Glargine: Glargine once a day (QD); Glargine QD + 1 Lispro (noon or PM); Glargine QD + 2 Lispro (noon and PM); Glargine QD + 3 Lispro.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had a measurement for the dependent variable at the time point, according to intent-to-treat (ITT) principles.'}, {'type': 'SECONDARY', 'title': 'HbA1c Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'OG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}], 'classes': [{'title': '16 weeks (n=142,n=140)', 'categories': [{'measurements': [{'value': '7.57', 'groupId': 'OG000', 'lowerLimit': '7.38', 'upperLimit': '7.75'}, {'value': '7.62', 'groupId': 'OG001', 'lowerLimit': '7.43', 'upperLimit': '7.81'}]}]}, {'title': '32 weeks (n=119, n=121)', 'categories': [{'measurements': [{'value': '7.43', 'groupId': 'OG000', 'lowerLimit': '7.22', 'upperLimit': '7.63'}, {'value': '7.46', 'groupId': 'OG001', 'lowerLimit': '7.26', 'upperLimit': '7.67'}]}]}, {'title': '48 weeks (n=115,n=125)', 'categories': [{'measurements': [{'value': '7.40', 'groupId': 'OG000', 'lowerLimit': '7.20', 'upperLimit': '7.61'}, {'value': '7.33', 'groupId': 'OG001', 'lowerLimit': '7.13', 'upperLimit': '7.53'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.29', 'estimateComment': 'Least squares mean difference = (Premix insulin Lispro - Glargine). 16 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.29', 'estimateComment': 'Least squares mean difference = (Premix insulin Lispro - Glargine). 32 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.18', 'estimateComment': 'Least squares mean difference = (Premix insulin Lispro - Glargine). 48 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '16 weeks, 32 weeks, and 48 weeks', 'description': 'Least Squares Mean (LSMean) values were adjusted based on a mixed effect linear regression model with a participant specific random effect: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) + visit + visit\\*treatment in Full Analysis Set (FAS) Population.', 'unitOfMeasure': 'percent glycosylated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'OG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}], 'classes': [{'title': 'Week 16 HbA1c <=7.0% (n=157, n=155)', 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000'}, {'value': '30.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 HbA1c <=6.5% (n=157, n=155)', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '18.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 HbA1c <=7.0% (n=137, n=141)', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}, {'value': '37.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 HbA1c <=6.5% (n=137, n=141)', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '20.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 HbA1c <=7.0% (n=130, n=137)', 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000'}, {'value': '48.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 HbA1c <=6.5% (n=130, n=137)', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000'}, {'value': '24.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2127', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Week 16 HbA1c \\<=7.0%.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3281', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Week 16 HbA1c \\<=6.5%', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2812', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Week 32 HbA1c \\<=7.0%', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6963', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Week 32 HbA1c \\<=6.5%', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0643', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Week 48 HbA1c \\<=7.0%', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2524', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Week 48 HbA1c \\<=6.5%', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks, 32 weeks and 48 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.'}, {'type': 'SECONDARY', 'title': '7-point Self-monitored Blood Glucose Profiles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'OG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}], 'classes': [{'title': 'Week 16 Before Breakfast (n=142, n=145)', 'categories': [{'measurements': [{'value': '6.94', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '7.36', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 Before Breakfast (n=126, n=130)', 'categories': [{'measurements': [{'value': '6.65', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '7.20', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Before Breakfast (n=123, n=130)', 'categories': [{'measurements': [{'value': '6.79', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '6.94', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 After Breakfast (n=136, n=138)', 'categories': [{'measurements': [{'value': '9.12', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '9.92', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 After Breakfast (n=123, n=127)', 'categories': [{'measurements': [{'value': '8.65', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '9.16', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 After Breakfast (n=120, n=129)', 'categories': [{'measurements': [{'value': '8.88', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '8.94', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 Before Lunch (n=143, n=145)', 'categories': [{'measurements': [{'value': '7.33', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '7.66', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 Before Lunch (n=128, n=132)', 'categories': [{'measurements': [{'value': '7.00', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '7.25', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Before Lunch (n=121, n=129)', 'categories': [{'measurements': [{'value': '7.14', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 After Lunch (n=138, n=140)', 'categories': [{'measurements': [{'value': '9.32', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '9.37', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 After Lunch (n=127, n=130)', 'categories': [{'measurements': [{'value': '8.34', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '8.69', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 After Lunch (n=120, n=126)', 'categories': [{'measurements': [{'value': '8.58', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '8.34', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 Before Dinner (n=143, n=145)', 'categories': [{'measurements': [{'value': '7.84', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '7.92', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 Before Dinner (n=129, n=132)', 'categories': [{'measurements': [{'value': '7.31', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '7.39', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Before Dinner (n=120, n=129)', 'categories': [{'measurements': [{'value': '7.55', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '7.19', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 After Dinner (n=140, n=141)', 'categories': [{'measurements': [{'value': '9.68', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '9.03', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 After Dinner (n=128, n=131)', 'categories': [{'measurements': [{'value': '8.64', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '8.50', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 After Dinner (n=120, n=126)', 'categories': [{'measurements': [{'value': '8.87', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '8.09', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 at 0300 Hours (n=114, n=120)', 'categories': [{'measurements': [{'value': '7.34', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '7.22', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 at 0300 Hours (n=105, n=106)', 'categories': [{'measurements': [{'value': '6.94', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '6.80', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 at 0300 Hours (n=104, n=107)', 'categories': [{'measurements': [{'value': '6.94', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '6.57', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '16 weeks, 32 weeks and 48 weeks', 'unitOfMeasure': 'millimoles per Liter (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.'}, {'type': 'SECONDARY', 'title': 'Mean Postprandial Blood Glucose Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'OG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}], 'classes': [{'title': 'Baseline (N=160, N=158)', 'categories': [{'measurements': [{'value': '6.25', 'spread': '5.804', 'groupId': 'OG000'}, {'value': '5.69', 'spread': '4.426', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (N=143, N=141)', 'categories': [{'measurements': [{'value': '9.69', 'spread': '6.161', 'groupId': 'OG000'}, {'value': '9.52', 'spread': '5.767', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 (N=125, N=123)', 'categories': [{'measurements': [{'value': '10.54', 'spread': '7.098', 'groupId': 'OG000'}, {'value': '10.81', 'spread': '6.824', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (N=119, N=125)', 'categories': [{'measurements': [{'value': '10.90', 'spread': '6.661', 'groupId': 'OG000'}, {'value': '11.41', 'spread': '7.344', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6615', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Baseline', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9798', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Week 16', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6169', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 32', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7834', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 48', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 16 weeks, 32 weeks and 48 weeks', 'description': 'Mean postprandial blood glucose values were assessed using GlycoMark, which is an FDA-approved blood test measuring levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma. When 1,5 AG values decrease, serum glucose levels increase.', 'unitOfMeasure': 'microgram per milliliter (µg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.'}, {'type': 'SECONDARY', 'title': 'Mean Daily Total, Basal and Prandial Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'OG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}], 'classes': [{'title': 'Week 16 Total Daily Insulin (N=156, N=155)', 'categories': [{'measurements': [{'value': '29.94', 'spread': '18.523', 'groupId': 'OG000'}, {'value': '26.94', 'spread': '15.398', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 Total Daily Insulin (N=135, N=140)', 'categories': [{'measurements': [{'value': '40.80', 'spread': '27.037', 'groupId': 'OG000'}, {'value': '38.45', 'spread': '23.876', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Total Daily Insulin (N=130, N=137)', 'categories': [{'measurements': [{'value': '46.45', 'spread': '31.402', 'groupId': 'OG000'}, {'value': '46.20', 'spread': '28.396', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 Basal Insulin (N=156, N=155)', 'categories': [{'measurements': [{'value': '25.53', 'spread': '13.239', 'groupId': 'OG000'}, {'value': '17.97', 'spread': '10.636', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 Basal Insulin (N=135, N=140)', 'categories': [{'measurements': [{'value': '30.05', 'spread': '16.211', 'groupId': 'OG000'}, {'value': '25.06', 'spread': '15.763', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Basal Insulin (N=130, N=137)', 'categories': [{'measurements': [{'value': '31.52', 'spread': '17.194', 'groupId': 'OG000'}, {'value': '30.12', 'spread': '18.612', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 Prandial Insulin (N=156, N=155)', 'categories': [{'measurements': [{'value': '4.41', 'spread': '9.181', 'groupId': 'OG000'}, {'value': '8.97', 'spread': '5.472', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 Prandial Insulin (N=135, N=140)', 'categories': [{'measurements': [{'value': '10.75', 'spread': '14.901', 'groupId': 'OG000'}, {'value': '13.39', 'spread': '8.599', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Prandial Insulin (N=130, N=137)', 'categories': [{'measurements': [{'value': '14.94', 'spread': '19.082', 'groupId': 'OG000'}, {'value': '16.07', 'spread': '10.280', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks, 32 weeks and 48 weeks', 'unitOfMeasure': 'International Units per day (IU/day)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.'}, {'type': 'SECONDARY', 'title': 'Body Weight Change From Baseline to Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'OG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}], 'classes': [{'categories': [{'measurements': [{'value': '2.70', 'groupId': 'OG000', 'lowerLimit': '2.09', 'upperLimit': '3.31'}, {'value': '2.61', 'groupId': 'OG001', 'lowerLimit': '2.01', 'upperLimit': '3.21'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '0.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'estimateComment': 'Least Squares Mean Difference = Premix Insulin Lispro minus Glargine.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 48 weeks', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.'}, {'type': 'SECONDARY', 'title': 'Incidence of All Self-reported Hypoglycemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'OG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}], 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'groupId': 'OG000'}, {'value': '64.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4935', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Percentage of participants with self-reported hypoglycemic episodes at any time during the study. A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose level of ≤70 mg/dL (3.9 mmol/L) (Roche plasma glucose) or ≤75 mg/dL (4.2 mmol/L) (IFCC Plasma Values), even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.'}, {'type': 'SECONDARY', 'title': 'Rate Per 30 Days of All Self-reported Hypoglycemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'OG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'spread': '1.106', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '1.587', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 48 weeks', 'description': 'The hypoglycemia rate between two visits will be calculated as the total number of episodes between the two visits divided by the number of days between the visits, and then multiplied by 30 days (rate per patient per 30 days).', 'unitOfMeasure': 'episodes per 30 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'OG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'TEAE', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 48 weeks', 'description': 'A summary of serious adverse events (SAEs) and all other non-serious treatment-emergent adverse events (TEAE) is located in the Reported Adverse Event Module.\n\nTEAEs are defined as events that are newly reported after randomization or reported to worsen in severity from baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population: All participants who received at least one dose of study drug during the treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'FG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)'}, {'id': 'BG001', 'title': 'Premix Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.24', 'spread': '8.621', 'groupId': 'BG000'}, {'value': '54.33', 'spread': '8.944', 'groupId': 'BG001'}, {'value': '54.29', 'spread': '8.770', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}, {'title': 'African', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}, {'title': 'East Asian', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'West Asian', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Portugal', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Egypt', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Glycosylated Hemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '9.07', 'spread': '0.988', 'groupId': 'BG000'}, {'value': '8.98', 'spread': '0.945', 'groupId': 'BG001'}, {'value': '9.02', 'spread': '0.966', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent glycosylated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-09', 'studyFirstSubmitDate': '2008-04-21', 'resultsFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2008-04-21', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-09', 'studyFirstPostDateStruct': {'date': '2008-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint', 'timeFrame': '48 weeks', 'description': 'Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Using Each Possible Final Insulin Regimen', 'timeFrame': '48 weeks', 'description': 'Insulin Regimens:\n\nLispro: Mid-Mix (MM) before noon; Low-Mix (LM) before evening (PM); MM before noon+LM before PM; LM before morning (AM)+MM before noon + LM before PM; MM before AM +MM before noon+LM before PM Glargine: Glargine once a day (QD); Glargine QD + 1 Lispro (noon or PM); Glargine QD + 2 Lispro (noon and PM); Glargine QD + 3 Lispro.'}, {'measure': 'HbA1c Over Time', 'timeFrame': '16 weeks, 32 weeks, and 48 weeks', 'description': 'Least Squares Mean (LSMean) values were adjusted based on a mixed effect linear regression model with a participant specific random effect: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) + visit + visit\\*treatment in Full Analysis Set (FAS) Population.'}, {'measure': 'Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time', 'timeFrame': '16 weeks, 32 weeks and 48 weeks'}, {'measure': '7-point Self-monitored Blood Glucose Profiles', 'timeFrame': '16 weeks, 32 weeks and 48 weeks'}, {'measure': 'Mean Postprandial Blood Glucose Values', 'timeFrame': 'Baseline, 16 weeks, 32 weeks and 48 weeks', 'description': 'Mean postprandial blood glucose values were assessed using GlycoMark, which is an FDA-approved blood test measuring levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma. When 1,5 AG values decrease, serum glucose levels increase.'}, {'measure': 'Mean Daily Total, Basal and Prandial Insulin Dose', 'timeFrame': '16 weeks, 32 weeks and 48 weeks'}, {'measure': 'Body Weight Change From Baseline to Endpoint', 'timeFrame': 'baseline, 48 weeks'}, {'measure': 'Incidence of All Self-reported Hypoglycemic Episodes', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Percentage of participants with self-reported hypoglycemic episodes at any time during the study. A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose level of ≤70 mg/dL (3.9 mmol/L) (Roche plasma glucose) or ≤75 mg/dL (4.2 mmol/L) (IFCC Plasma Values), even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005).'}, {'measure': 'Rate Per 30 Days of All Self-reported Hypoglycemic Episodes', 'timeFrame': 'Baseline to 48 weeks', 'description': 'The hypoglycemia rate between two visits will be calculated as the total number of episodes between the two visits divided by the number of days between the visits, and then multiplied by 30 days (rate per patient per 30 days).'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Baseline to 48 weeks', 'description': 'A summary of serious adverse events (SAEs) and all other non-serious treatment-emergent adverse events (TEAE) is located in the Reported Adverse Event Module.\n\nTEAEs are defined as events that are newly reported after randomization or reported to worsen in severity from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes Mellitus, Type 2\n* have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione \\[TZD\\]) without insulin, for at least 90 days prior to Visit 1\n* glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%\n* regularly consume a light breakfast (less than 15% of total daily calorie intake)\n* capable and willing to follow the protocol\n* give written consent\n\nExclusion Criteria:\n\n* are taking a TZD whose country label does not allow in combination with insulin\n* are taking any glucose-lowering agents (other than specified in the inclusion criteria above)\n* have a body mass index greater than 40 kg/m\\^2\n* have a history of severe hypoglycemia in past 24 weeks\n* are pregnant or may become pregnant\n* women who are breastfeeding\n* have significant cardiac disease\n* have significant renal or liver disease\n* undergoing therapy for a malignancy\n* contraindications to study medications\n* have an irregular sleep/wake cycle'}, 'identificationModule': {'nctId': 'NCT00664534', 'briefTitle': 'Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Comparison of Premixed Insulin Lispro Low-Mixture and Mid-Mixture Regimens With Separate Basal and Bolus Insulin Injections in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Oral Therapy Who Consume Light Breakfast', 'orgStudyIdInfo': {'id': '11806'}, 'secondaryIdInfos': [{'id': 'F3Z-EW-S020', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'CTRI/2009/091/000609', 'type': 'REGISTRY', 'domain': 'India Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glargine', 'description': 'Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)', 'interventionNames': ['Drug: Insulin Glargine']}, {'type': 'EXPERIMENTAL', 'label': 'Premixed Insulin Lispro', 'description': 'Premixed Insulin Lispro (mid-mixture or low-mixture) 1,2 or 3 injections plus OAMs', 'interventionNames': ['Drug: Insulin Lispro Premix (mid-mixture and low-mixture)']}], 'interventions': [{'name': 'Insulin Glargine', 'type': 'DRUG', 'description': 'patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks', 'armGroupLabels': ['Glargine']}, {'name': 'Insulin Lispro Premix (mid-mixture and low-mixture)', 'type': 'DRUG', 'otherNames': ['LY275585'], 'description': 'patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks', 'armGroupLabels': ['Premixed Insulin Lispro']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7A 4W8', 'city': 'Smiths Falls', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.90452, 'lon': -76.02333}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Bāb al Lūq', 'country': 'Egypt', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.04458, 'lon': 31.23997}}, {'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Heliopolis', 'country': 'Egypt', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.10882, 'lon': 31.37924}}, {'zip': '380006', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '500033', 'city': 'Hyderabaad', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '452001', 'city': 'Indore', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 22.71792, 'lon': 75.8333}}, {'zip': '400053', 'city': 'Mumbai', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '96400', 'city': 'Coatzacoalcos', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 18.14905, 'lon': -94.4447}}, {'zip': '06700', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '3814-501', 'city': 'Aveiro', 'country': 'Portugal', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.64575, 'lon': -8.64643}}, {'zip': '2830', 'city': 'Barreiro', 'country': 'Portugal', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.66314, 'lon': -9.0724}}, {'zip': '1250-203', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4099-001', 'city': 'Porto', 'country': 'Portugal', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '020359', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '200000', 'city': 'Craiova', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '6200', 'city': 'Galati', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.43687, 'lon': 28.05028}}, {'zip': '70057', 'city': 'Iași', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '03114', 'city': 'Alicante', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08915', 'city': 'Badalona', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '38320', 'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '06510', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '07070', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}, {'zip': '42075', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 am-5 pm Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}