Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-02 @ 4:03 AM
Study NCT ID:
NCT02318693
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2014-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, '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': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'D005905', 'term': 'Glyburide'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential may be deleted prior to submission; this confidentiality does not include efficacy and safety results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 4 weeks', 'description': 'The All Subjects as Treated (ASaT) population consisting of all participants who received at least one dose of study treatment was used for analysis of safety.', 'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin 50 mg', 'description': 'Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.', 'otherNumAtRisk': 26, 'otherNumAffected': 11, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Glibenclamide 2.50 mg TDD', 'description': 'Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.', 'otherNumAtRisk': 26, 'otherNumAffected': 10, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA ver. 18.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA ver. 18.0'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA ver. 18.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA ver. 18.0'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA ver. 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 50 mg', 'description': 'Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.'}, {'id': 'OG001', 'title': 'Glibenclamide 2.50 mg TDD', 'description': 'Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.5', 'groupId': 'OG000', 'lowerLimit': '-30.0', 'upperLimit': '-7.1'}, {'value': '-9.7', 'groupId': 'OG001', 'lowerLimit': '-21.1', 'upperLimit': '1.6'}]}]}], 'analyses': [{'pValue': '0.245', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.8', 'ciLowerLimit': '-23.8', 'ciUpperLimit': '6.2', 'groupDescription': 'The comparison was conducted at the α=0.05 (2-sided) significance level.', 'statisticalMethod': 'constrained longitudinal analysis model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -2) and Day 13', 'description': 'MAGE is a popular metric for assessment of major (e.g., postprandial) glucose swings. MAGE is calculated as the average of differences between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of 24-hour mean glucose. In this assessment, glucose levels were determined using continuous glucose monitoring (CGM) over 24 hours at Baseline and Day 13; CGM values were further corrected for blood glucose values obtained via participant-administered finger-stick. Least squares (LS) means values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Standard Deviation of Blood Glucose Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 50 mg', 'description': 'Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.'}, {'id': 'OG001', 'title': 'Glibenclamide 2.50 mg TDD', 'description': 'Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.2', 'groupId': 'OG000', 'lowerLimit': '-14.4', 'upperLimit': '-6.0'}, {'value': '-4.2', 'groupId': 'OG001', 'lowerLimit': '-8.4', 'upperLimit': '-0.1'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.9', 'ciLowerLimit': '-11.3', 'ciUpperLimit': '-0.6', 'groupDescription': 'The comparison was conducted at the α=0.05 (2-sided) significance level.', 'statisticalMethod': 'constrained longitudinal analysis model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -2) and Day 13', 'description': 'SD is a popular metric for assessment of postprandial glucose swings. The SD of all glycemic excursions over 24 hours (i.e., total of 288 glucose values over 24 hours) was determined for Baseline and Day 13. Original values were obtained using CGM and corrected for blood glucose values obtained via participant-administered finger-stick. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 50 mg', 'description': 'Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.'}, {'id': 'OG001', 'title': 'Glibenclamide 2.50 mg TDD', 'description': 'Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.'}], 'classes': [{'title': 'Breakfast', 'categories': [{'measurements': [{'value': '-24.8', 'groupId': 'OG000', 'lowerLimit': '-34.1', 'upperLimit': '-15.6'}, {'value': '-12.0', 'groupId': 'OG001', 'lowerLimit': '-21.1', 'upperLimit': '-2.9'}]}]}, {'title': 'Lunch', 'categories': [{'measurements': [{'value': '-13.2', 'groupId': 'OG000', 'lowerLimit': '-24.0', 'upperLimit': '-2.3'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '-9.6', 'upperLimit': '11.9'}]}]}, {'title': 'Dinner', 'categories': [{'measurements': [{'value': '-9.0', 'groupId': 'OG000', 'lowerLimit': '-20.9', 'upperLimit': '2.9'}, {'value': '-14.1', 'groupId': 'OG001', 'lowerLimit': '-25.9', 'upperLimit': '-2.3'}]}]}], 'analyses': [{'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.8', 'ciLowerLimit': '-25.1', 'ciUpperLimit': '-0.5', 'groupDescription': 'Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Breakfast. The comparison was conducted at the α=0.05 (2-sided) significance level.', 'statisticalMethod': 'constrained longitudinal analysis model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.'}, {'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.3', 'ciLowerLimit': '-28.1', 'ciUpperLimit': '-0.5', 'groupDescription': 'Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Lunch. The comparison was conducted at the α=0.05 (2-sided) significance level.', 'statisticalMethod': 'constrained longitudinal analysis model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.'}, {'pValue': '0.509', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '20.4', 'groupDescription': 'Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Dinner. The comparison was conducted at the α=0.05 (2-sided) significance level.', 'statisticalMethod': 'constrained longitudinal analysis model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -2) and Day 13', 'description': 'The peak postprandial glucose level during the 3 hours post meal minus the preprandial glucose level 1 hour before meal was determined for corrected CGM values at Baseline and Day 13 for breakfast, lunch, and dinner. Meals were standardized with respect to total calories, and protein, fat, and carbohydrate composition as well as timing of administration. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates better control of postprandial glucose.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-hour Mean Glucose Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 50 mg', 'description': 'Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.'}, {'id': 'OG001', 'title': 'Glibenclamide 2.50 mg TDD', 'description': 'Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.1', 'groupId': 'OG000', 'lowerLimit': '-28.5', 'upperLimit': '-9.7'}, {'value': '-34.8', 'groupId': 'OG001', 'lowerLimit': '-44.0', 'upperLimit': '-25.5'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.7', 'ciLowerLimit': '2.5', 'ciUpperLimit': '28.8', 'groupDescription': 'The comparison was conducted at the α=0.05 (2-sided) significance level.', 'statisticalMethod': 'constrained longitudinal analysis model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -2) and Day 13', 'description': 'The mean glucose level over 24-hours at Baseline and Day 13 was determined using CGM values corrected for participant-administered finger-stick values. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 50 mg', 'description': 'Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.'}, {'id': 'OG001', 'title': 'Glibenclamide 2.50 mg TDD', 'description': 'Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.'}], 'classes': [{'title': '<70 mg/dL', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '1.0'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '2.1'}]}]}, {'title': '<60 mg/dL', 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '0.5'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '1.1'}]}]}, {'title': '<50 mg/dL', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '0.2'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '0.2'}]}]}], 'analyses': [{'pValue': '0.134', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '0.3', 'groupDescription': 'Comparison: Change in Baseline in Percentage of Hypoglycemic Values \\< 70 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.', 'statisticalMethod': 'constrained longitudinal analysis model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.226', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.4', 'groupDescription': 'Comparison: Change in Baseline in Percentage of Hypoglycemic Values \\< 60 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.', 'statisticalMethod': 'constrained longitudinal analysis model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.332', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.0', 'groupDescription': 'Comparison: Change in Baseline in Percentage of Hypoglycemic Values \\< 50 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.', 'statisticalMethod': 'constrained longitudinal analysis model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day -2) and Day 13', 'description': 'Hypoglycemia, defined as low blood glucose, is a common side effect of medications used to treat diabetes mellitus type 2. The percentage of hypoglycemic corrected CGM readings (sensor glucose \\<70, \\<60, \\<50 mg/dL) over a 24-hour period were determined at baseline and Day 13. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates improvement in occurrence of hypoglycemia.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin 50 mg', 'description': 'Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.'}, {'id': 'FG001', 'title': 'Glibenclamide 2.50 mg TDD', 'description': 'Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'comment': '1 randomized participant did not receive treatment.', 'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Screening for study inclusion was performed over a 4-week period. Adults with type 2 diabetes were randomized into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin 50 mg', 'description': 'Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.'}, {'id': 'BG001', 'title': 'Glibenclamide 2.50 mg TDD', 'description': 'Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.2', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '59.5', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '59.8', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '70.2', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '70.7', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '70.5', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '169.5', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '169.3', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '169.4', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '24.6', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '24.5', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes Mellitus', 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '9.9', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '8.2', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Status', 'classes': [{'title': 'Current Smoker', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Ex-Smoker', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Never Smoked', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol Consumption', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': '1 to 4', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': '>5', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Drinks/week'}, {'title': 'Hemoglobin A1C (HbA1C)', 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '7.9', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '7.8', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Glycosylated HbA1c is a surrogate marker of long-term glycemic control. The permissible range for study inclusion was ≥ 7.0% and \\< 9.0% (National Glycohemoglobin Standardization program; NGSP) at Week -2.', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline data is provided for the Full Analysis Set (FAS) population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for analysis, and with applicable baseline data.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2015-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2014-12-12', 'resultsFirstSubmitDate': '2016-11-21', 'studyFirstSubmitQcDate': '2014-12-12', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-28', 'studyFirstPostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13', 'timeFrame': 'Baseline (Day -2) and Day 13', 'description': 'MAGE is a popular metric for assessment of major (e.g., postprandial) glucose swings. MAGE is calculated as the average of differences between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of 24-hour mean glucose. In this assessment, glucose levels were determined using continuous glucose monitoring (CGM) over 24 hours at Baseline and Day 13; CGM values were further corrected for blood glucose values obtained via participant-administered finger-stick. Least squares (LS) means values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Standard Deviation of Blood Glucose Levels', 'timeFrame': 'Baseline (Day -2) and Day 13', 'description': 'SD is a popular metric for assessment of postprandial glucose swings. The SD of all glycemic excursions over 24 hours (i.e., total of 288 glucose values over 24 hours) was determined for Baseline and Day 13. Original values were obtained using CGM and corrected for blood glucose values obtained via participant-administered finger-stick. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.'}, {'measure': 'Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal', 'timeFrame': 'Baseline (Day -2) and Day 13', 'description': 'The peak postprandial glucose level during the 3 hours post meal minus the preprandial glucose level 1 hour before meal was determined for corrected CGM values at Baseline and Day 13 for breakfast, lunch, and dinner. Meals were standardized with respect to total calories, and protein, fat, and carbohydrate composition as well as timing of administration. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates better control of postprandial glucose.'}, {'measure': 'Change From Baseline in 24-hour Mean Glucose Level', 'timeFrame': 'Baseline (Day -2) and Day 13', 'description': 'The mean glucose level over 24-hours at Baseline and Day 13 was determined using CGM values corrected for participant-administered finger-stick values. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.'}, {'measure': 'Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL)', 'timeFrame': 'Baseline (Day -2) and Day 13', 'description': 'Hypoglycemia, defined as low blood glucose, is a common side effect of medications used to treat diabetes mellitus type 2. The percentage of hypoglycemic corrected CGM readings (sensor glucose \\<70, \\<60, \\<50 mg/dL) over a 24-hour period were determined at baseline and Day 13. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates improvement in occurrence of hypoglycemia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '29770541', 'type': 'DERIVED', 'citation': 'Suzuki R, Eiki JI, Moritoyo T, Furihata K, Wakana A, Ohta Y, Tokita S, Kadowaki T. Effect of short-term treatment with sitagliptin or glibenclamide on daily glucose fluctuation in drug-naive Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2018 Sep;20(9):2274-2281. doi: 10.1111/dom.13364. Epub 2018 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on the glucose variability using continuous glucose monitoring (CGM) in Japanese participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with sitagliptin will be superior to treatment with glibenclamide in the change from baseline in mean amplitude of glycemic excursions (MAGE) through continuous glucose monitoring (CGM) after 13 days of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese participants with a diagnosis of Type 2 diabetes mellitus\n\nExclusion Criteria:\n\n* History of Type 1 diabetes mellitus or ketoacidosis\n* History of insulin or thiazolidinedione (including fixed-dose drug combinations containing one of these drugs) in the 12 weeks before study participation'}, 'identificationModule': {'nctId': 'NCT02318693', 'briefTitle': 'Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Open-label, Comparative Clinical Trial to Study the Efficacy of Sitagliptin and Glibenclamide in a Short Term Treatment on the Daily Glucose Variability Using Continuous Glucose Monitoring (CGM) in Japanese Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '0431-355'}, 'secondaryIdInfos': [{'id': '152867', 'type': 'REGISTRY', 'domain': 'JAPIC-CTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin 50 mg', 'description': 'Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.', 'interventionNames': ['Drug: Sitagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glibenclamide 2.50 mg TDD', 'description': 'Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.', 'interventionNames': ['Drug: Glibenclamide']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['MK-0431'], 'description': 'Sitagliptin 50 mg orally once a day before breakfast for 14 days', 'armGroupLabels': ['Sitagliptin 50 mg']}, {'name': 'Glibenclamide', 'type': 'DRUG', 'description': 'Glibenclamide 1.25 mg orally twice a day (2.5 mg/day) before breakfast and dinner for 14 days', 'armGroupLabels': ['Glibenclamide 2.50 mg TDD']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}