Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT00698932
Status:
COMPLETED
Last Update Posted:
2011-09-21
First Post:
2008-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C502994', 'term': 'saxagliptin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'The Principal Investigator undertakes to provide AstraZeneca as soon as possible with preliminary data and drafts of proposed publications and disclosures, whether oral or in writing, and as soon as available, with the proposed final manuscript. AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks', 'otherNumAtRisk': 284, 'otherNumAffected': 18, 'seriousNumAtRisk': 284, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo tablet, once daily( OD) for 24 weeks', 'otherNumAtRisk': 284, 'otherNumAffected': 22, 'seriousNumAtRisk': 284, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}], 'seriousEvents': [{'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Anal Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Renal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet, once daily( OD) for 24 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.15', 'spread': '0.050', 'groupId': 'OG000'}, {'value': '8.14', 'spread': '0.050', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '7.25', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '7.75', 'spread': '0.076', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted Mean Change from Baseline', 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.065', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.079', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '\\*adjusted for baseline HbA1c', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline , Week 24', 'description': 'Adjusted\\* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.'}, {'type': 'SECONDARY', 'title': 'Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet, once daily( OD) for 24 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.15', 'spread': '0.125', 'groupId': 'OG000'}, {'value': '9.05', 'spread': '0.141', 'groupId': 'OG001'}]}]}, {'title': 'week 24', 'categories': [{'measurements': [{'value': '8.10', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '8.77', 'spread': '0.163', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted mean change from Baseline', 'categories': [{'measurements': [{'value': '-0.90', 'spread': '0.144', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.141', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '-0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.170', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '\\*adjusted for baseline FPG', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted\\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.'}, {'type': 'SECONDARY', 'title': 'Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet, once daily( OD) for 24 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '164.85', 'spread': '2.253', 'groupId': 'OG000'}, {'value': '163.03', 'spread': '2.543', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '145.97', 'spread': '2.317', 'groupId': 'OG000'}, {'value': '158.04', 'spread': '2.942', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted mean change from Baseline', 'categories': [{'measurements': [{'value': '-16.13', 'spread': '2.586', 'groupId': 'OG000'}, {'value': '-3.01', 'spread': '2.544', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-13.12', 'ciLowerLimit': '-19.12', 'ciUpperLimit': '-7.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.053', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '\\*adjusted for baseline FPG', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted\\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.'}, {'type': 'SECONDARY', 'title': 'Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet, once daily( OD) for 24 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2474', 'spread': '46.9', 'groupId': 'OG000'}, {'value': '2506', 'spread': '64.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '2063', 'spread': '41.1', 'groupId': 'OG000'}, {'value': '2262', 'spread': '57.6', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted mean change from Baseline', 'categories': [{'measurements': [{'value': '-417', 'spread': '36.5', 'groupId': 'OG000'}, {'value': '-235', 'spread': '40.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciPctValue': '95', 'paramValue': '-182', 'ciLowerLimit': '-289', 'ciUpperLimit': '-74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '54.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '\\*adjusted for baseline PPG AUC', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline , Week 24', 'description': 'Adjusted\\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication', 'unitOfMeasure': 'mmol*min/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.'}, {'type': 'SECONDARY', 'title': 'Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet, once daily( OD) for 24 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '44586', 'spread': '844.8', 'groupId': 'OG000'}, {'value': '45146', 'spread': '1170.5', 'groupId': 'OG001'}]}]}, {'title': 'week 24', 'categories': [{'measurements': [{'value': '37166', 'spread': '739.6', 'groupId': 'OG000'}, {'value': '40751', 'spread': '1036.6', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted mean change from Baseline', 'categories': [{'measurements': [{'value': '-7534', 'spread': '657.4', 'groupId': 'OG000'}, {'value': '-4255', 'spread': '726.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-3280', 'ciLowerLimit': '-5214', 'ciUpperLimit': '-1345', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '980.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '\\*adjusted for baseline PPG AUC', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline , Week 24', 'description': 'Adjusted\\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication', 'unitOfMeasure': 'mg*min/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had baseline and post-baseline data. Measurements observed on and after rescue medication were excluded.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet, once daily( OD) for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000'}, {'value': '28.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciPctValue': '95', 'paramValue': '17.0', 'ciLowerLimit': '8.9', 'ciUpperLimit': '24.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'Proportion of participants (expressed in percentage of total participants) achieving HbA1c \\< 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo tablet, once daily( OD) for 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized and treated', 'groupId': 'FG000', 'numSubjects': '284'}, {'comment': 'Randomized and treated', 'groupId': 'FG001', 'numSubjects': '284'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 24 Weeks of treatment', 'groupId': 'FG000', 'numSubjects': '262'}, {'comment': 'Completed 24 Weeks of treatment', 'groupId': 'FG001', 'numSubjects': '248'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Incorrect enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Study specific discontinuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Severe non-compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Safety reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '568', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Saxagliptin 5 mg', 'description': 'Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo tablet, once daily( OD) for 24 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.23', 'spread': '10.04', 'groupId': 'BG000'}, {'value': '51.57', 'spread': '10.34', 'groupId': 'BG001'}, {'value': '51.4', 'spread': '10.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 568}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-17', 'studyFirstSubmitDate': '2008-06-16', 'resultsFirstSubmitDate': '2010-09-20', 'studyFirstSubmitQcDate': '2008-06-16', 'lastUpdatePostDateStruct': {'date': '2011-09-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-17', 'studyFirstPostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline , Week 24', 'description': 'Adjusted\\* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted\\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.'}, {'measure': 'Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)', 'timeFrame': 'Baseline, Week 24', 'description': 'Adjusted\\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.'}, {'measure': 'Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants', 'timeFrame': 'Baseline , Week 24', 'description': 'Adjusted\\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication'}, {'measure': 'Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants', 'timeFrame': 'Baseline , Week 24', 'description': 'Adjusted\\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication'}, {'measure': 'Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Proportion of participants (expressed in percentage of total participants) achieving HbA1c \\< 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['DPP-4 inhibitors', 'HBA1c', 'Incretins'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '27402391', 'type': 'DERIVED', 'citation': 'Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients with inadequate glycaemic control with diet and exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Type 2 diabetes\n* Patients should be drug naïve ie, not received medical treatment for diabetes,\n* HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)\n\nExclusion Criteria:\n\n* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes),\n* Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma'}, 'identificationModule': {'nctId': 'NCT00698932', 'briefTitle': 'Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise.', 'orgStudyIdInfo': {'id': 'D1680C00005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saxagliptin 5mg', 'interventionNames': ['Drug: Saxagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Saxagliptin', 'type': 'DRUG', 'otherNames': ['Onglyza'], 'description': '5mg, oral tablet, once daily for 24 weeks', 'armGroupLabels': ['Saxagliptin 5mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral tablet, once daily for 24 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 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