Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-02 @ 7:18 AM
Study NCT ID:
NCT02577003
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2015-10-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Double-blind Ipragliflozin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin (MK-0431J-843)
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': 'C572941', 'term': 'ipragliflozin'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Dvelopment', '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 must be deleted prior to submission; this confidentiality does not include efficacy and safety results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 26 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Ipragliflozin + Sitagliptin', 'description': 'Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.', 'otherNumAtRisk': 73, 'otherNumAffected': 12, 'seriousNumAtRisk': 73, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo + Sitagliptin', 'description': 'Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.', 'otherNumAtRisk': 70, 'otherNumAffected': 15, 'seriousNumAtRisk': 70, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipragliflozin + Sitagliptin', 'description': 'Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}, {'id': 'OG001', 'title': 'Placebo + Sitagliptin', 'description': 'Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.84', 'groupId': 'OG000', 'lowerLimit': '-0.99', 'upperLimit': '-0.69'}, {'value': '-0.07', 'groupId': 'OG001', 'lowerLimit': '-0.22', 'upperLimit': '0.09'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.77', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '-0.57', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on a cLDA model with the terms listed above.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. Statistical analysis based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline HbA1c is the same for both treatment groups.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of HbA1c (baseline or post-baseline).'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipragliflozin + Sitagliptin', 'description': 'Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}, {'id': 'OG001', 'title': 'Placebo + Sitagliptin', 'description': 'Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000'}, {'value': '65.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 26 weeks', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued Study Drug Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipragliflozin + Sitagliptin', 'description': 'Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}, {'id': 'OG001', 'title': 'Placebo + Sitagliptin', 'description': 'Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipragliflozin + Sitagliptin', 'description': 'Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}, {'id': 'OG001', 'title': 'Placebo + Sitagliptin', 'description': 'Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.3', 'groupId': 'OG000', 'lowerLimit': '-35.5', 'upperLimit': '-25.0'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-7.6', 'upperLimit': '3.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.1', 'ciLowerLimit': '-34.8', 'ciUpperLimit': '-21.5', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on a cLDA model with the terms listed above.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline FPG is the same for both treatment groups.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of FPG (baseline or post-baseline).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-hr PMG at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipragliflozin + Sitagliptin', 'description': 'Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}, {'id': 'OG001', 'title': 'Placebo + Sitagliptin', 'description': 'Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}], 'classes': [{'categories': [{'measurements': [{'value': '-52.4', 'groupId': 'OG000', 'lowerLimit': '-61.5', 'upperLimit': '-43.2'}, {'value': '-3.8', 'groupId': 'OG001', 'lowerLimit': '-13.3', 'upperLimit': '5.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-48.5', 'ciLowerLimit': '-59.6', 'ciUpperLimit': '-37.5', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on a cLDA model with the terms listed above.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in 2-hr PMG at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline 2-hr PMG is the same for both treatment groups.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of 2-hr PMG (baseline or post-baseline).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glucose Total AUC0-2hr After Meal at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipragliflozin + Sitagliptin', 'description': 'Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}, {'id': 'OG001', 'title': 'Placebo + Sitagliptin', 'description': 'Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}], 'classes': [{'categories': [{'measurements': [{'value': '-86.9', 'groupId': 'OG000', 'lowerLimit': '-101.0', 'upperLimit': '-72.9'}, {'value': '-2.3', 'groupId': 'OG001', 'lowerLimit': '-17.0', 'upperLimit': '12.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-84.6', 'ciLowerLimit': '-102.6', 'ciUpperLimit': '-66.6', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on a cLDA model with the terms listed above.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24 (just before the loading meal [0 min], 30 min, 60 min and 120 min)', 'description': 'Change from baseline in glucose total AUC0-2hr after meal at Week 24 is defined as Week 24 glucose total AUC0-2hr after a meal minus Week 0 glucose total AUC0-2hr after a meal. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline glucose total AUC0-2hr after meal is the same for both treatment groups.', 'unitOfMeasure': 'mg･hr/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of glucose total AUC0-2hr after meal (baseline or post-baseline).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ipragliflozin + Sitagliptin', 'description': 'Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}, {'id': 'OG001', 'title': 'Placebo + Sitagliptin', 'description': 'Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '-1.9'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '-0.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '-1.1', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on a cLDA model with the terms listed above.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in body weight at Week 24 is defined as Week 24 body weight minus Week 0 body weight. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline body weight is the same for both treatment groups.', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of body weight after meal (baseline or post-baseline).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ipragliflozin + Sitagliptin', 'description': 'Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}, {'id': 'FG001', 'title': 'Placebo + Sitagliptin', 'description': 'Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Prior to randomization, all participants received placebo for 2 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ipragliflozin + Sitagliptin', 'description': 'Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}, {'id': 'BG001', 'title': 'Placebo + Sitagliptin', 'description': 'Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '60.0', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '60.5', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '8.05', 'spread': '0.83', 'groupId': 'BG000'}, {'value': '7.99', 'spread': '0.62', 'groupId': 'BG001'}, {'value': '8.02', 'spread': '0.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Estimated Glomerular Filtration Rate (eGFR)', 'classes': [{'categories': [{'measurements': [{'value': '82.0', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '83.4', 'spread': '16.7', 'groupId': 'BG001'}, {'value': '82.7', 'spread': '15.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Plasma Glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '158.0', 'spread': '33.2', 'groupId': 'BG000'}, {'value': '163.0', 'spread': '26.2', 'groupId': 'BG001'}, {'value': '160.5', 'spread': '30.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '2-hour Post-Meal Glucose (2-hr PMG)', 'classes': [{'categories': [{'measurements': [{'value': '225.3', 'spread': '59.9', 'groupId': 'BG000'}, {'value': '231.5', 'spread': '48.9', 'groupId': 'BG001'}, {'value': '228.3', 'spread': '54.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glucose Total Area Under the Plasma Concentration Curve from Hour 0 to Hour 2 (AUC0-2hr) after Meal', 'classes': [{'categories': [{'measurements': [{'value': '429.4', 'spread': '86.3', 'groupId': 'BG000'}, {'value': '443.4', 'spread': '67.0', 'groupId': 'BG001'}, {'value': '436.2', 'spread': '77.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg･hr/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '69.8', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '70.1', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '69.9', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Prior use of other antihyperglycemic agents (AHAs)', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Other AHAs refers to the use of AHAs other than sitagliptin within 8 weeks of study start.', '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': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-03', 'studyFirstSubmitDate': '2015-10-14', 'resultsFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2015-10-14', 'lastUpdatePostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-07', 'studyFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. Statistical analysis based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline HbA1c is the same for both treatment groups.'}, {'measure': 'Percentage of Participants Who Experienced at Least One Adverse Event (AE)', 'timeFrame': 'Up to 26 weeks', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.'}, {'measure': 'Percentage of Participants Who Discontinued Study Drug Due to an AE', 'timeFrame': 'Up to 24 weeks', 'description': 'An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in FPG at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline FPG is the same for both treatment groups.'}, {'measure': 'Change From Baseline in 2-hr PMG at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in 2-hr PMG at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline 2-hr PMG is the same for both treatment groups.'}, {'measure': 'Change From Baseline in Glucose Total AUC0-2hr After Meal at Week 24', 'timeFrame': 'Baseline and Week 24 (just before the loading meal [0 min], 30 min, 60 min and 120 min)', 'description': 'Change from baseline in glucose total AUC0-2hr after meal at Week 24 is defined as Week 24 glucose total AUC0-2hr after a meal minus Week 0 glucose total AUC0-2hr after a meal. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline glucose total AUC0-2hr after meal is the same for both treatment groups.'}, {'measure': 'Change From Baseline in Body Weight at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in body weight at Week 24 is defined as Week 24 body weight minus Week 0 body weight. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline body weight is the same for both treatment groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '34033212', 'type': 'DERIVED', 'citation': "Kaku K, Kadowaki T, Seino Y, Okamoto T, Shirakawa M, Sato A, O'Neill EA, Engel SS, Kaufman KD. Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on sitagliptin. Diabetes Obes Metab. 2021 Sep;23(9):2099-2108. doi: 10.1111/dom.14448. Epub 2021 Jun 15."}]}, 'descriptionModule': {'briefSummary': 'This is a study to assess the safety and efficacy of the addition of ipragliflozin once daily in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy. The primary hypothesis for this study is that the addition of ipragliflozin compared with placebo provides greater reduction in hemoglobin A1C (HbA1c) as assessed by change from baseline at Week 24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy\n* HbA1c ≥7.0% and ≤10.0% before study start\n\nExclusion Criteria:\n\n* History of Type 1 diabetes mellitus or a history of ketoacidosis\n* History of any of the following medications: thiazolidinediones (TZD) and/or insulin within 12 weeks prior to study participation and sodium glucose cotransporter 2 (SGLT2) inhibitors anytime\n* Currently has a urinary tract infection or genital infection with subjective symptom'}, 'identificationModule': {'nctId': 'NCT02577003', 'briefTitle': 'Double-blind Ipragliflozin Add-on Study in Japanese Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin (MK-0431J-843)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Trial to Assess the Safety and Efficacy of Addition of Ipragliflozin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin Monotherapy in Addition to Diet and Exercise Therapy', 'orgStudyIdInfo': {'id': '0431J-843'}, 'secondaryIdInfos': [{'id': '153097', 'type': 'REGISTRY', 'domain': 'JAPIC-CTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ipragliflozin + Sitagliptin', 'description': 'Ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.', 'interventionNames': ['Drug: Ipragliflozin', 'Drug: Sitagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + Sitagliptin', 'description': 'Placebo to ipragliflozin once daily for 24 weeks in addition to sitagliptin, diet, and exercise.', 'interventionNames': ['Drug: Placebo', 'Drug: Sitagliptin']}], 'interventions': [{'name': 'Ipragliflozin', 'type': 'DRUG', 'description': '50 mg tablet administered orally', 'armGroupLabels': ['Ipragliflozin + Sitagliptin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to ipragliflozin tablet administered orally', 'armGroupLabels': ['Placebo + Sitagliptin']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia®, Tesavel®, Xelevia®, Ristaben®, Glactiv®'], 'description': 'Background medication; 50 mg tablet administered orally', 'armGroupLabels': ['Ipragliflozin + Sitagliptin', 'Placebo + Sitagliptin']}]}, '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'}}}}