Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-31 @ 9:46 AM
Study NCT ID:
NCT00792935
Status:
COMPLETED
Last Update Posted:
2015-12-17
First Post:
2008-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'Colombia', 'Denmark', 'Estonia', 'Finland', 'India', 'Ireland', 'Italy', 'Malaysia', 'Norway', 'Poland', 'Russia', 'Sweden', 'Taiwan', 'United States']}, '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': 'C569222', 'term': '3-((6-(ethylsulfonyl)-3-pyridinyl)oxy)-5-(2-hydroxy-1-methylethoxy)-N-(1-methyl-1H-pyrazol-3-yl)benzamide'}, {'id': 'C057619', 'term': 'glimepiride'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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 study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '14 weeks', 'description': 'All randomized participants who received at least one dose of MK-0941 or glimepiride. Assessments during regular visits to the site (every 2 to 4 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'MK-0941', 'description': 'All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941.', 'otherNumAtRisk': 72, 'otherNumAffected': 31, 'seriousNumAtRisk': 72, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Glimepiride', 'description': 'All patients as treated (APaT) defined as all randomized participants who received at least one dose of glimepiride.', 'otherNumAtRisk': 71, 'otherNumAffected': 25, 'seriousNumAtRisk': 71, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 89, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 78, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0941', 'description': 'Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \\[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\\], after a 4-week dose titration/dose stabilization period.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \\[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\\], after a 4-week dose titration/dose stabilization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.4', 'groupId': 'OG000', 'lowerLimit': '-50.0', 'upperLimit': '-36.8'}, {'value': '-44.2', 'groupId': 'OG001', 'lowerLimit': '-50.9', 'upperLimit': '-37.5'}]}]}], 'analyses': [{'pValue': '0.847', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '9.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.4', 'groupDescription': 'Using a standard deviation of 23.5 mg/dL, a sample size of at least 65 participants per treatment group would be required to have an 80% power to detect a true difference of 12.5 mg/dL between MK-0941 and glimepiride as measured by change from baseline in 24-hour WMG at Week 6.', 'statisticalMethod': 'Constrained longitudinal analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) population included all randomized participants who had efficacy measurements at baseline or a post-randomization visit).'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-0941', 'description': 'Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \\[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\\], after a 4-week dose titration/dose stabilization period.'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \\[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\\], after a 4-week dose titration/dose stabilization period.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.361', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.7', 'ciLowerLimit': '-23.6', 'ciUpperLimit': '8.7', 'estimateComment': 'The estimated value represents the difference in percentages, MK-0941 minus Glimepiride.', 'statisticalMethod': 'Miettinen & Nurminen method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 6', 'description': 'Hypoglycemic episodes are defined as either a fingerstick glucose\n\nmeasurement of ≤70 mg/dL \\[3.9 mmol/L\\] with or without symptoms or symptomatic hypoglycemia.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941 or glimepiride.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK-0941', 'description': 'Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \\[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\\], after a 4-week dose titration/dose stabilization period.'}, {'id': 'FG001', 'title': 'Glimepiride', 'description': 'Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \\[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\\], after a 4-week dose titration/dose stabilization period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MK-0941', 'description': 'Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \\[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\\], after a 4-week dose titration/dose stabilization period.'}, {'id': 'BG001', 'title': 'Glimepiride', 'description': 'Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin \\[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\\], after a 4-week dose titration/dose stabilization period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '55.2', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '55', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean 24-Hour Weighted Mean Glucose at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '178.8', 'spread': '33.9', 'groupId': 'BG000'}, {'value': '184.4', 'spread': '38.4', 'groupId': 'BG001'}, {'value': '181.6', 'spread': '36.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], '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': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-16', 'studyFirstSubmitDate': '2008-11-14', 'resultsFirstSubmitDate': '2012-06-28', 'studyFirstSubmitQcDate': '2008-11-17', 'lastUpdatePostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-31', 'studyFirstPostDateStruct': {'date': '2008-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose', 'timeFrame': 'Baseline and Week 6', 'description': 'Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.'}, {'measure': 'Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)', 'timeFrame': 'Baseline to Week 6', 'description': 'Hypoglycemic episodes are defined as either a fingerstick glucose\n\nmeasurement of ≤70 mg/dL \\[3.9 mmol/L\\] with or without symptoms or symptomatic hypoglycemia.'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking metformin for type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has type 2 diabetes mellitus\n* Between the ages of 18 and 70\n\nExclusion Criteria:\n\n* Patient has a history of type 1 diabetes mellitus or ketoacidosis.\n* Patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication.\n* Patient has had surgery within 30 days of starting the study or has planned major surgery during the study'}, 'identificationModule': {'nctId': 'NCT00792935', 'briefTitle': 'A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-Arm Clinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy', 'orgStudyIdInfo': {'id': '0941-017'}, 'secondaryIdInfos': [{'id': '2008_589'}, {'id': 'CTRI/2009/091/000154', 'type': 'REGISTRY', 'domain': 'CTRI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-0941', 'interventionNames': ['Drug: MK-0941', 'Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glimepiride', 'interventionNames': ['Drug: Glimepiride', 'Drug: Metformin']}], 'interventions': [{'name': 'MK-0941', 'type': 'DRUG', 'description': 'MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks.', 'armGroupLabels': ['MK-0941']}, {'name': 'Glimepiride', 'type': 'DRUG', 'otherNames': ['Amaryl®'], 'description': 'Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks.', 'armGroupLabels': ['Glimepiride']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin \\[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\\], the participant should remain on the same metformin dose throughout the study.', 'armGroupLabels': ['Glimepiride', 'MK-0941']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}