Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT00666458
Status:
COMPLETED
Last Update Posted:
2010-04-15
First Post:
2008-04-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)
Sponsor:
Organization:
Raw JSON
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'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Saxa + Met', 'description': 'Saxagliptin 5 mg tablets added on to open-label metformin', 'otherNumAtRisk': 403, 'otherNumAffected': 54, 'seriousNumAtRisk': 403, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Sita + Met', 'description': 'Sitagliptin 100 mg capsules added on to open-label metformin', 'otherNumAtRisk': 398, 'otherNumAffected': 50, 'seriousNumAtRisk': 398, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ulcer Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ROAD TRAFFIC ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypoglycaemic Unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Endometrial Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Aortic Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemoglobin A1c (HbA1c) Change From Baseline to Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxa + Met', 'description': 'Saxagliptin 5 mg tablets added on to open-label metformin'}, {'id': 'OG001', 'title': 'Sita + Met', 'description': 'Sitagliptin 100 mg capsules added on to open-label metformin'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.68', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '7.69', 'spread': '0.047', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '7.16', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '7.07', 'spread': '0.051', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted Change from Baseline', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.039', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.038', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.055', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 18', 'description': 'Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who completed the 18 weeks of treatment had both baseline and week 18 HbA1c measurement and had no significant protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxa + Met', 'description': 'Saxagliptin 5 mg tablets added on to open-label metformin'}, {'id': 'OG001', 'title': 'Sita + Met', 'description': 'Sitagliptin 100 mg capsules added on to open-label metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}, {'value': '29.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '3.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 18 (Last Observation Carried Forward)', 'description': 'Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c \\<= 6.5% at Week 18 (Full Analysis Set)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 18 LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxa + Met', 'description': 'Saxagliptin 5 mg tablets added on to open-label metformin'}, {'id': 'OG001', 'title': 'Sita + Met', 'description': 'Sitagliptin 100 mg capsules added on to open-label metformin'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '159.67', 'spread': '2.280', 'groupId': 'OG000'}, {'value': '160.22', 'spread': '2.192', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '149.04', 'spread': '1.991', 'groupId': 'OG000'}, {'value': '143.94', 'spread': '1.864', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted Change from Baseline', 'categories': [{'measurements': [{'value': '-10.75', 'spread': '1.455', 'groupId': 'OG000'}, {'value': '-16.16', 'spread': '1.464', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.42', 'ciLowerLimit': '1.37', 'ciUpperLimit': '9.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.064', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 18 (Last Observation Carried Forward)', 'description': 'Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.', '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 of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxa + Met', 'description': 'Saxagliptin 5 mg tablets added on to open-label metformin'}, {'id': 'OG001', 'title': 'Sita + Met', 'description': 'Sitagliptin 100 mg capsules added on to open-label metformin'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.86', 'spread': '0.127', 'groupId': 'OG000'}, {'value': '8.89', 'spread': '0.122', 'groupId': 'OG001'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '8.27', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '7.99', 'spread': '0.103', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted Change from Baseline', 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.081', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.115', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 18 (Last Observation Carried Forward)', 'description': 'Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.', '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 of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Saxa + Met', 'description': 'Saxagliptin 5 mg tablets added on to open-label metformin'}, {'id': 'FG001', 'title': 'Sita + Met', 'description': 'Sitagliptin 100 mg capsules added on to open-label metformin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized and treated', 'groupId': 'FG000', 'numSubjects': '403'}, {'comment': 'Randomized and treated', 'groupId': 'FG001', 'numSubjects': '398'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 18 weeks of treatment', 'groupId': 'FG000', 'numSubjects': '365'}, {'comment': 'Completed 18 weeks of treatment', 'groupId': 'FG001', 'numSubjects': '374'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Administrative reason by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Incorrect enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study specific discontinuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Severe non-compliance to the protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Safety reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Medical history of anemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '801', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Saxa + Met', 'description': 'Saxagliptin 5 mg tablets added on to open-label metformin'}, {'id': 'BG001', 'title': 'Sita + Met', 'description': 'Sitagliptin 100 mg capsules added on to open-label metformin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.77', 'spread': '10.14', 'groupId': 'BG000'}, {'value': '58.07', 'spread': '10.51', 'groupId': 'BG001'}, {'value': '58.42', 'spread': '10.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '392', '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': 822}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-05', 'studyFirstSubmitDate': '2008-04-23', 'resultsFirstSubmitDate': '2010-03-05', 'studyFirstSubmitQcDate': '2008-04-24', 'lastUpdatePostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-05', 'studyFirstPostDateStruct': {'date': '2008-04-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c (HbA1c) Change From Baseline to Week 18', 'timeFrame': 'Baseline, Week 18', 'description': 'Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18', 'timeFrame': 'Week 18 (Last Observation Carried Forward)', 'description': 'Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c \\<= 6.5% at Week 18 (Full Analysis Set)'}, {'measure': 'Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)', 'timeFrame': 'Baseline, Week 18 (Last Observation Carried Forward)', 'description': 'Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.'}, {'measure': 'Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)', 'timeFrame': 'Baseline, Week 18 (Last Observation Carried Forward)', 'description': 'Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'metformin'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes\n* Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks\n\nExclusion Criteria:\n\n* Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma\n* Insulin therapy within one year\n* Previous treatment with DPP-4 inhibitor'}, 'identificationModule': {'nctId': 'NCT00666458', 'briefTitle': '18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With T2D Who Have Inadequate Glycaemic Control on Metformin Alone', 'orgStudyIdInfo': {'id': 'D1680C00002'}, 'secondaryIdInfos': [{'id': 'EudraCT number 2007-006095-11'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'saxagliptin add-on to metformin', 'interventionNames': ['Drug: saxagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'sitagliptin add-on to metformin', 'interventionNames': ['Drug: sitagliptin']}], 'interventions': [{'name': 'saxagliptin', 'type': 'DRUG', 'otherNames': ['Onglyza'], 'description': 'tablet, per oral, once daily', 'armGroupLabels': ['1']}, {'name': 'sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia'], 'description': 'capsule, per oral, once daily', 'armGroupLabels': ['2']}]}, 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