Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-28 @ 7:19 PM
Study NCT ID:
NCT01340768
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2011-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, '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': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'C057619', 'term': 'glimepiride'}, {'id': 'D008687', 'term': 'Metformin'}], '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': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, '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 Principal Investigator shall not publish any article or paper nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations, relating or referring to the following: (a) the study or any results, data or insight there from; (b) the services performed; or (c) any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.', 'otherNumAtRisk': 421, 'otherNumAffected': 16, 'seriousNumAtRisk': 421, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Sulfonylurea Therapy', 'description': 'Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.', 'otherNumAtRisk': 427, 'otherNumAffected': 33, 'seriousNumAtRisk': 427, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypoglycemia', 'notes': 'Hypoglycemia includes both symptomatic hypoglycemia and asymptomatic hypoglycemia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 427, 'numEvents': 63, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 421, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 427, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Symptomatic Hypoglycemic Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100mg taken orally once daily, with or without metformin'}, {'id': 'OG001', 'title': 'Sulfonylurea Therapy', 'description': 'Usual sulfonylurea therapy and dose for each participant, with or without metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.29', 'ciUpperLimit': '0.94', 'pValueComment': 'P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days (Day 1 through last day of Ramadan)', 'description': 'Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants as treated population defined as all randomized participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100mg taken orally once daily, with or without metformin'}, {'id': 'OG001', 'title': 'Sulfonylurea Therapy', 'description': 'Usual sulfonylurea therapy and dose for each participant, with or without metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.29', 'ciUpperLimit': '0.83', 'pValueComment': 'P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days (Day 1 through last day of Ramadan)', 'description': 'Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). Asymptomatic hypoglycemic events were based on self-monitored finger-stick blood glucose level.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants as treated population defined as all randomized participants who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100mg taken orally once daily, with or without metformin'}, {'id': 'FG001', 'title': 'Sulfonylurea Therapy', 'description': 'Usual sulfonylurea therapy and dose for each participant, with or without metformin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '436'}, {'groupId': 'FG001', 'numSubjects': '434'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '419'}, {'groupId': 'FG001', 'numSubjects': '429'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'BG000'}, {'value': '427', 'groupId': 'BG001'}, {'value': '848', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.'}, {'id': 'BG001', 'title': 'Sulfonylurea Therapy', 'description': 'Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '80'}, {'value': '50.7', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '78'}, {'value': '51.0', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '446', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 870}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2011-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2011-03-24', 'resultsFirstSubmitDate': '2012-09-07', 'studyFirstSubmitQcDate': '2011-04-21', 'lastUpdatePostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-09-07', 'studyFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With at Least One Symptomatic Hypoglycemic Event', 'timeFrame': 'Up to 30 days (Day 1 through last day of Ramadan)', 'description': 'Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event', 'timeFrame': 'Up to 30 days (Day 1 through last day of Ramadan)', 'description': 'Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). Asymptomatic hypoglycemic events were based on self-monitored finger-stick blood glucose level.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glucose metabolism disorders Metabolic diseases Peptidase inhibitors'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '37435938', 'type': 'DERIVED', 'citation': 'Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.'}, {'pmid': '22738801', 'type': 'DERIVED', 'citation': 'Aravind SR, Ismail SB, Balamurugan R, Gupta JB, Wadhwa T, Loh SM, Suryawanshi S, Davies MJ, Girman CJ, Katzeff HL, Radican L, Engel SS, Wolthers T. Hypoglycemia in patients with type 2 diabetes from India and Malaysia treated with sitagliptin or a sulfonylurea during Ramadan: a randomized, pragmatic study. Curr Med Res Opin. 2012 Aug;28(8):1289-96. doi: 10.1185/03007995.2012.707119. Epub 2012 Jul 6.'}]}, 'descriptionModule': {'briefSummary': 'This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.', 'detailedDescription': 'This study and NCT01131182 (MK-0431-263) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Muslim, with type 2 diabetes mellitus\n* Intends to fast during the month of Ramadan\n* Hemoglobin A1c (HbA1c) ≤10% at screening\n* On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at least three months, with or without metformin therapy at a stable dose\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Pregnant or breast feeding or with gestational diabetes\n* Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment\n* Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females)\n* History of severe hypoglycemia (defined as a hypoglycemic event requiring the assistance of another individual, and/or resulting in a emergency department admission, physician office visit and/or hospitalization)\n* Any use of insulin (prior to or during Ramadan)\n* Use of any class of oral antidiabetic therapy other than an SU or metformin\n* Current participation in another interventional study'}, 'identificationModule': {'nctId': 'NCT01340768', 'briefTitle': 'Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting', 'orgStudyIdInfo': {'id': '0431-262'}, 'secondaryIdInfos': [{'id': 'CTRI/2011/06/001838', 'type': 'REGISTRY', 'domain': 'CTRI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin', 'description': 'Sitagliptin 100mg taken orally once daily with or without metformin', 'interventionNames': ['Drug: Sitagliptin', 'Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sulfonylurea Therapy', 'description': 'Usual sulfonylurea therapy with or without metformin', 'interventionNames': ['Drug: Sulfonylurea', 'Drug: Metformin']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Sitagliptin phosphate, MK-0431, JANUVIA®'], 'description': 'One 100 mg tablet taken orally once daily', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Sulfonylurea', 'type': 'DRUG', 'otherNames': ['Amaryl (glimepiride)'], 'description': 'Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.', 'armGroupLabels': ['Sulfonylurea Therapy']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.', 'armGroupLabels': ['Sitagliptin', 'Sulfonylurea Therapy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}