Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-04 @ 1:47 PM
Study NCT ID:
NCT02273050
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2014-10-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502994', 'term': 'saxagliptin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Eva.Johnsson@astrazeneca.com', 'phone': '46 31 7762484', 'title': 'Eva Johnsson, MD, PhD', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Total number at risk is number of patients in safety analysis set (out of 640 randomized, 1 did not take study drug).', 'eventGroups': [{'id': 'EG000', 'title': 'METFORMIN + PLACEBO 5MG QD', 'otherNumAtRisk': 210, 'otherNumAffected': 30, 'seriousNumAtRisk': 210, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'SAXAGLIPTIN 5MG QD + METFORMIN', 'otherNumAtRisk': 215, 'otherNumAffected': 37, 'seriousNumAtRisk': 215, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'SAXAGLIPTIN 5MG QD + PLACEBO', 'otherNumAtRisk': 214, 'otherNumAffected': 21, 'seriousNumAtRisk': 214, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatitis alcoholic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Adrenal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Glomerulonephritis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c From Baseline to Week 24 Provided That it is Prior to Rescue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin + Metformin', 'description': 'Saxagliptin 5 mg + Metformin 500 mg'}, {'id': 'OG001', 'title': 'Saxagliptin + Placebo', 'description': 'Saxagliptin 5 mg + Placebo'}, {'id': 'OG002', 'title': 'Metformin + Placebo', 'description': 'Metformin 500 mg + Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.007', 'spread': '0.0706', 'groupId': 'OG000', 'lowerLimit': '-3.146', 'upperLimit': '-2.869'}, {'value': '-2.123', 'spread': '0.0701', 'groupId': 'OG001', 'lowerLimit': '-2.260', 'upperLimit': '-1.985'}, {'value': '-2.794', 'spread': '0.0715', 'groupId': 'OG002', 'lowerLimit': '-2.935', 'upperLimit': '-2.654'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.885', 'ciLowerLimit': '-1.080', 'ciUpperLimit': '-0.689', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0994', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.034', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.213', 'ciLowerLimit': '-0.410', 'ciUpperLimit': '-0.016', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1005', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24 (prior to rescue)', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in HbA1c (%) at the end of 24 weeks of double-blinded treatment.', 'unitOfMeasure': '% HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.'}, {'type': 'SECONDARY', 'title': 'Glycemic Response Defined as HbA1c < 7.0% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin + Metformin', 'description': 'Saxagliptin 5 mg + Metformin 500 mg'}, {'id': 'OG001', 'title': 'Saxagliptin + Placebo', 'description': 'Saxagliptin 5 mg + Placebo'}, {'id': 'OG002', 'title': 'Metformin + Placebo', 'description': 'Metformin 500 mg + Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}, {'value': '44.3', 'groupId': 'OG001'}, {'value': '71.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.5', 'ciLowerLimit': '29.0', 'ciUpperLimit': '46.0', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.7', 'ciLowerLimit': '2.6', 'ciUpperLimit': '18.9', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 (prior to rescue)', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c \\< 7.0% at the end of 24 weeks of double-blinded treatment.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 (Prior to Rescue) in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '207', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin + Metformin', 'description': 'Saxagliptin 5 mg + Metformin 500 mg'}, {'id': 'OG001', 'title': 'Saxagliptin + Placebo', 'description': 'Saxagliptin 5 mg + Placebo'}, {'id': 'OG002', 'title': 'Metformin + Placebo', 'description': 'Metformin 500 mg + Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.25', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '-1.86', 'spread': '0.111', 'groupId': 'OG001'}, {'value': '-2.94', 'spread': '0.113', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.39', 'ciLowerLimit': '-1.70', 'ciUpperLimit': '-1.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.158', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.046', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.159', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24 prior to rescue', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in fasting plasma glucose at the end of 24 weeks of double-blinded treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 (Prior to Rescue) in Area Under the Curve From 0-180 Minutes for Postprandial Glucose Response to a Meal Tolerance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin + Metformin', 'description': 'Saxagliptin 5 mg + Metformin 500 mg'}, {'id': 'OG001', 'title': 'Saxagliptin + Placebo', 'description': 'Saxagliptin 5 mg + Placebo'}, {'id': 'OG002', 'title': 'Metformin + Placebo', 'description': 'Metformin 500 mg + Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1027.8', 'spread': '36.22', 'groupId': 'OG000'}, {'value': '-611.9', 'spread': '36.69', 'groupId': 'OG001'}, {'value': '-858.5', 'spread': '37.36', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-416.0', 'ciLowerLimit': '-517.3', 'ciUpperLimit': '-314.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '51.54', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-169.3', 'ciLowerLimit': '-271.7', 'ciUpperLimit': '-66.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '52.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24 prior to rescue', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 180-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment.', 'unitOfMeasure': 'mmol*min/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration, and participated in a meal tolerance test.'}, {'type': 'SECONDARY', 'title': 'Glycemic Response Defined as HbA1c ≤ 6.5% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin + Metformin', 'description': 'Saxagliptin 5 mg + Metformin 500 mg'}, {'id': 'OG001', 'title': 'Saxagliptin + Placebo', 'description': 'Saxagliptin 5 mg + Placebo'}, {'id': 'OG002', 'title': 'Metformin + Placebo', 'description': 'Metformin 500 mg + Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'groupId': 'OG000'}, {'value': '32.1', 'groupId': 'OG001'}, {'value': '55.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.9', 'ciLowerLimit': '26.0', 'ciUpperLimit': '43.9', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.6', 'ciLowerLimit': '2.3', 'ciUpperLimit': '20.9', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 (prior to rescue)', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c ≤ 6.5% at the end of 24 weeks of double-blinded treatment.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in 120-minute Postprandial Glucose Response to a Meal Tolerance Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin + Metformin', 'description': 'Saxagliptin 5 mg + Metformin 500 mg'}, {'id': 'OG001', 'title': 'Saxagliptin + Placebo', 'description': 'Saxagliptin 5 mg + Placebo'}, {'id': 'OG002', 'title': 'Metformin + Placebo', 'description': 'Metformin 500 mg + Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.09', 'spread': '0.261', 'groupId': 'OG000'}, {'value': '-4.12', 'spread': '0.262', 'groupId': 'OG001'}, {'value': '-5.95', 'spread': '0.268', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.97', 'ciLowerLimit': '-3.70', 'ciUpperLimit': '-2.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.370', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.14', 'ciLowerLimit': '-1.88', 'ciUpperLimit': '-0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.374', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24 prior to rescue', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 120-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration, and participated in a meal tolerance test.'}, {'type': 'SECONDARY', 'title': 'Patients Rescued for Failing to Achieve Pre-specified Glycemic Targets or Discontinuation for Lack of Efficacy During the 24-week Double-blind Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '207', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin + Metformin', 'description': 'Saxagliptin 5 mg + Metformin 500 mg'}, {'id': 'OG001', 'title': 'Saxagliptin + Placebo', 'description': 'Saxagliptin 5 mg + Placebo'}, {'id': 'OG002', 'title': 'Metformin + Placebo', 'description': 'Metformin 500 mg + Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.9', 'ciLowerLimit': '-13.3', 'ciUpperLimit': '-4.5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '>0.999', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '2.3', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24 weeks of double-blinded treatment.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'METFORMIN + PLACEBO 5MG QD'}, {'id': 'FG001', 'title': 'SAXAGLIPTIN 5MG QD + METFORMIN'}, {'id': 'FG002', 'title': 'SAXAGLIPTIN 5MG QD + PLACEBO'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '216'}, {'groupId': 'FG002', 'numSubjects': '214'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '194'}, {'groupId': 'FG002', 'numSubjects': '185'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Dev. of study spec. withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study was conducted in 25 centers between 18 December 2014 and 03 August 2016.', 'preAssignmentDetails': 'The study duration was up to 27 weeks, consisting of an initial screening period lasting up to 2 weeks, a 1-week lead-in period, and a 24-week treatment period. The number of subjects who signed the ICF is 1136, the number of subjects randomized is 640.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}, {'value': '640', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'METFORMIN + PLACEBO 5MG QD'}, {'id': 'BG001', 'title': 'SAXAGLIPTIN 5MG QD + METFORMIN'}, {'id': 'BG002', 'title': 'SAXAGLIPTIN 5MG QD + PLACEBO'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'spread': '11.08', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '75'}, {'value': '50.4', 'spread': '10.78', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '74'}, {'value': '49.5', 'spread': '10.93', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '74'}, {'value': '50.0', 'spread': '10.92', 'groupId': 'BG003', 'lowerLimit': '20', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '214', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '426', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}, {'value': '640', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', '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': 1136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2014-10-22', 'resultsFirstSubmitDate': '2017-08-01', 'studyFirstSubmitQcDate': '2014-10-22', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-01', 'studyFirstPostDateStruct': {'date': '2014-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c From Baseline to Week 24 Provided That it is Prior to Rescue', 'timeFrame': 'Baseline to Week 24 (prior to rescue)', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in HbA1c (%) at the end of 24 weeks of double-blinded treatment.'}], 'secondaryOutcomes': [{'measure': 'Glycemic Response Defined as HbA1c < 7.0% at Week 24', 'timeFrame': 'Week 24 (prior to rescue)', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c \\< 7.0% at the end of 24 weeks of double-blinded treatment.'}, {'measure': 'Change From Baseline to Week 24 (Prior to Rescue) in Fasting Plasma Glucose', 'timeFrame': 'Baseline to Week 24 prior to rescue', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in fasting plasma glucose at the end of 24 weeks of double-blinded treatment.'}, {'measure': 'Change From Baseline to Week 24 (Prior to Rescue) in Area Under the Curve From 0-180 Minutes for Postprandial Glucose Response to a Meal Tolerance Test', 'timeFrame': 'Baseline to Week 24 prior to rescue', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 180-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment.'}, {'measure': 'Glycemic Response Defined as HbA1c ≤ 6.5% at Week 24', 'timeFrame': 'Week 24 (prior to rescue)', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c ≤ 6.5% at the end of 24 weeks of double-blinded treatment.'}, {'measure': 'Change From Baseline to Week 24 in 120-minute Postprandial Glucose Response to a Meal Tolerance Test', 'timeFrame': 'Baseline to Week 24 prior to rescue', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 120-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment.'}, {'measure': 'Patients Rescued for Failing to Achieve Pre-specified Glycemic Targets or Discontinuation for Lack of Efficacy During the 24-week Double-blind Treatment Phase', 'timeFrame': 'Baseline to Week 24', 'description': 'To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24 weeks of double-blinded treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus, Dipeptidyl-Peptidase 4 Inhibitors, Saxagliptin, Metformin, Endocrine System Diseases'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '28926170', 'type': 'DERIVED', 'citation': 'Dou J, Ma J, Liu J, Wang C, Johnsson E, Yao H, Zhao J, Pan C. Efficacy and safety of saxagliptin in combination with metformin as initial therapy in Chinese patients with type 2 diabetes: Results from the START study, a multicentre, randomized, double-blind, active-controlled, phase 3 trial. Diabetes Obes Metab. 2018 Mar;20(3):590-598. doi: 10.1111/dom.13117. Epub 2017 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control', 'detailedDescription': 'Allocation: Randomized Endpoint Classification: Efficacy/Safety study Intervention Model: Parallel Assignment Masking: Double Blind Primary Purpose: Treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Subjects with type 2 diabetes mellitus; 2. HbA1c ≥8% but ≤12%; 3.Fasting C-peptide ≥1.0 ng/ml; 4. Subject will be drug naïve; 5. Body mass index ≤40 kg/m2.\n\nExclusion Criteria:\n\n1\\. Symptoms of poorly controlled diabetes; 2. Chronic or repeated intermittent corticosteroid treatment ; 3. Calculated creatinine clearance \\<60 ml/min or serum creatinine \\>132.6 μmol/L (\\>1.5 mg/dL) for men, \\>123.8 μmol/L (\\>1.4 mg/dL) for women; 4. Creatine Kinase ≥3x ULN; 5.Abnormal TSH value at screening will be further evaluated by free T4, subjects with an abnormal free T4 will be excluded; 6. History of administration of any antihyperglycaemic therapy for a total of 28 days or for more than three consecutive days or a total of seven non-consecutive days during the eight weeks prior to screening; 7. Current treatment with a strong CYP3A4/5 inhibitor; 8. Prior treatment with saxagliptin or any DPP-4 inhibitor; 9. Significant or history of cardiovascular disease, renal disease, psychiatric disorders, Immunocompromised individuals, hemoglobinopathies, liver disease, Pancreatitis.'}, 'identificationModule': {'nctId': 'NCT02273050', 'briefTitle': 'Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control', 'orgStudyIdInfo': {'id': 'D1680C00009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saxagliptin 5 mg + Metformin (500 mg with titration)', 'description': 'Saxagliptin 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed.', 'interventionNames': ['Drug: Saxagliptin 5 mg', 'Drug: Metformin 500 mg with titration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saxagliptin 5 mg + Placebo', 'description': 'Saxagliptin 5 mg once daily and Placebo 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed.', 'interventionNames': ['Drug: Saxagliptin 5 mg', 'Drug: Placebo 500 mg for metformin (with titration)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin (500 mg with titration) + Placebo', 'description': 'Placebo 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed.', 'interventionNames': ['Drug: Placebo 5 mg for Saxagliptin', 'Drug: Metformin 500 mg with titration']}], 'interventions': [{'name': 'Saxagliptin 5 mg', 'type': 'DRUG', 'otherNames': ['Onglyza', 'BMS-477118'], 'description': 'Tablet, Oral, 5 mg, Once daily in the morning', 'armGroupLabels': ['Saxagliptin 5 mg + Metformin (500 mg with titration)', 'Saxagliptin 5 mg + Placebo']}, {'name': 'Placebo 5 mg for Saxagliptin', 'type': 'DRUG', 'description': 'Tablet, Oral, 5 mg, Once daily in the morning', 'armGroupLabels': ['Metformin (500 mg with titration) + Placebo']}, {'name': 'Placebo 500 mg for metformin (with titration)', 'type': 'DRUG', 'description': 'Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.', 'armGroupLabels': ['Saxagliptin 5 mg + Placebo']}, {'name': 'Metformin 500 mg with titration', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.', 'armGroupLabels': ['Metformin (500 mg with titration) + Placebo', 'Saxagliptin 5 mg + Metformin (500 mg with titration)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Chuangchun', 'country': 'China', 'facility': 'Research Site'}, {'city': 'Fuzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guiyang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'city': 'Hangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Ha’erbin', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.8696, 'lon': 101.742}}, {'city': 'Hefei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Jinan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Nanchang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Nanjing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shijiazhuang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Siping', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 43.16143, 'lon': 124.37785}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Wuxi', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'city': 'Yueyang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 29.37455, 'lon': 113.09481}}], 'overallOfficials': [{'name': 'Changyu Pan, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The General Hospital of People's liberation Army"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}