Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT00683657
Status:
COMPLETED
Last Update Posted:
2015-06-01
First Post:
2008-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
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': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Boaz Hirschberg', 'organization': 'AstraZeneca Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PLACEBO + MET', 'otherNumAtRisk': 47, 'otherNumAffected': 5, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SAXA 5MG + MET', 'otherNumAtRisk': 46, 'otherNumAffected': 1, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.'}, {'id': 'OG001', 'title': 'Placebo + Metformin', 'description': 'Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.'}], 'classes': [{'title': 'Baseline Mean', 'categories': [{'measurements': [{'value': '177.5', 'spread': '4.99', 'groupId': 'OG000'}, {'value': '181.2', 'spread': '6.30', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Mean', 'categories': [{'measurements': [{'value': '163.8', 'spread': '5.09', 'groupId': 'OG000'}, {'value': '184.2', 'spread': '7.05', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted Mean Change from Baseline', 'categories': [{'measurements': [{'value': '-13.8', 'spread': '2.99', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.8', 'ciLowerLimit': '-25.1', 'ciUpperLimit': '-8.5', 'pValueComment': 'Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.16', 'estimateComment': 'Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin.', 'groupDescription': 'With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: post - pre = pre treatment', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for 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 an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.'}, {'id': 'OG001', 'title': 'Placebo + Metformin', 'description': 'Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.'}], 'classes': [{'title': 'Baseline Mean', 'categories': [{'measurements': [{'value': '212.1', 'spread': '6.80', 'groupId': 'OG000'}, {'value': '211.1', 'spread': '6.60', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Mean', 'categories': [{'measurements': [{'value': '181.4', 'spread': '6.79', 'groupId': 'OG000'}, {'value': '210.8', 'spread': '8.02', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted Mean Change from Baseline', 'categories': [{'measurements': [{'value': '-30.7', 'spread': '5.14', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '4.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.2', 'ciLowerLimit': '-44.4', 'ciUpperLimit': '-16.1', 'pValueComment': 'Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.10', 'estimateComment': 'Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin', 'groupDescription': 'With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model: post - pre = pretreatment', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for 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 an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.'}, {'id': 'OG001', 'title': 'Placebo + Metformin', 'description': 'Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.'}], 'classes': [{'title': 'Baseline Mean', 'categories': [{'measurements': [{'value': '237.6', 'spread': '8.87', 'groupId': 'OG000'}, {'value': '233.1', 'spread': '7.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Mean', 'categories': [{'measurements': [{'value': '198.5', 'spread': '8.82', 'groupId': 'OG000'}, {'value': '231.1', 'spread': '9.22', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted Change from Baseline', 'categories': [{'measurements': [{'value': '-38.2', 'spread': '7.49', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '7.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.4', 'ciLowerLimit': '-56.2', 'ciUpperLimit': '-14.7', 'pValueComment': 'Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.41', 'estimateComment': 'Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin', 'groupDescription': 'With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model: post - pre = pretreatment', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'Adjusted mean change from baseline in 2-hour postprandial plasma glucose after the evening meal during 24-hour domicile visits, evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for 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 an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Daily Glucose at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.'}, {'id': 'OG001', 'title': 'Placebo + Metformin', 'description': 'Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.'}], 'classes': [{'title': 'Baseline Mean', 'categories': [{'measurements': [{'value': '179.0', 'spread': '5.76', 'groupId': 'OG000'}, {'value': '184.9', 'spread': '7.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Mean', 'categories': [{'measurements': [{'value': '167.5', 'spread': '4.87', 'groupId': 'OG000'}, {'value': '191.8', 'spread': '8.41', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted Change from Baseline', 'categories': [{'measurements': [{'value': '-11.7', 'spread': '3.02', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '2.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.7', 'ciLowerLimit': '-27.1', 'ciUpperLimit': '-10.3', 'pValueComment': 'Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.22', 'estimateComment': 'Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin', 'groupDescription': 'With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: post - pre = pretreatment', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for 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 an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.'}, {'id': 'OG001', 'title': 'Placebo + Metformin', 'description': 'Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.'}], 'classes': [{'title': 'Baseline Mean', 'categories': [{'measurements': [{'value': '152.2', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '158.9', 'spread': '5.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Last Observation Carried Forward Mean', 'categories': [{'measurements': [{'value': '141.9', 'spread': '3.99', 'groupId': 'OG000'}, {'value': '162.9', 'spread': '6.00', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted Mean Change from Baseline', 'categories': [{'measurements': [{'value': '-10.8', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-23.3', 'ciUpperLimit': '-7.4', 'pValueComment': 'Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.00', 'estimateComment': 'Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin', 'groupDescription': 'With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: post - pre = pretreatment', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for 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 an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.'}, {'id': 'FG001', 'title': 'Placebo + Metformin', 'description': 'Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Randomized Subjects Data Set', 'achievements': [{'comment': 'Randomized subjects who took at least 1 dose of double-blind study medication.', 'groupId': 'FG000', 'numSubjects': '46'}, {'comment': 'Randomized subjects who took at least 1 dose of double-blind study medication.', 'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '218 subjects were enrolled and 128 entered the 4-week dietary and exercise, and metformin extended release (XR) lead-in period. Thirty-five subjects did not enter treatment period (21 no longer met study criteria, 7 withdrew consent, 7 for poor protocol compliance).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Saxagliptin 5 mg + Metformin', 'description': 'Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR.'}, {'id': 'BG001', 'title': 'Placebo + Metformin', 'description': 'Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.50', 'spread': '9.20', 'groupId': 'BG000'}, {'value': '55.77', 'spread': '9.14', 'groupId': 'BG001'}, {'value': '55.14', 'spread': '9.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years to <75 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-08', 'studyFirstSubmitDate': '2008-05-21', 'resultsFirstSubmitDate': '2010-02-19', 'studyFirstSubmitQcDate': '2008-05-21', 'lastUpdatePostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-19', 'studyFirstPostDateStruct': {'date': '2008-05-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.'}, {'measure': 'Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'Adjusted mean change from baseline in 2-hour postprandial plasma glucose after the evening meal during 24-hour domicile visits, evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.'}, {'measure': 'Change From Baseline in Mean Daily Glucose at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value.'}, {'measure': 'Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18- and ≤77-years-old\n* Type 2 diabetes\n* Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy\n* Glycosylated hemoglobin (A1C) ≥7% and ≤10%\n* Body mass index (BMI) ≤40 kg/m2\n\nExclusion Criteria:\n\n* Women of childbearing potential unable or unwilling to use acceptable birth control\n* Women who are pregnant or breastfeeding\n* Significant cardiovascular history\n* Active liver disease\n* Renal impairment'}, 'identificationModule': {'nctId': 'NCT00683657', 'briefTitle': 'Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial To Evaluate The Efficacy And Safety Of Saxagliptin In Comparison To Placebo As Add On Treatment To Metformin XR In Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin ≥1500 mg/Day', 'orgStudyIdInfo': {'id': 'CV181-066'}, 'secondaryIdInfos': [{'id': 'Eudract-2008-000976-26'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saxagliptin 5 mg + 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