Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-02 @ 7:58 AM
Study NCT ID:
NCT01718093
Status:
COMPLETED
Last Update Posted:
2017-04-24
First Post:
2012-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-12-30', 'releaseDate': '2020-12-04'}], 'estimatedResultsFirstSubmitDate': '2020-12-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'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': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2012-10-29', 'studyFirstSubmitQcDate': '2012-10-29', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the glucose lowering effect of metformin and sitagliptin alone and as combination therapy when used as adjuncts to insulin in adolescents with T1DM.', 'timeFrame': '10 - 15 weeks', 'description': 'Glucose concentrations and AUC glucose calculation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adolescents'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if the use of metformin and sitagliptin used in conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes.', 'detailedDescription': '* The study will include a total of 4 visits. The time period between the very first visit and the very last visit will be between 10 and 15 weeks. Each participant will be randomized to one of the 3 groups in the study. The groups are as follows:\n* Group 1: Insulin and sitagliptin\n* Group 2: Insulin and metformin\n* Group 3: Insulin and combination of sitagliptin and metformin\n* The study is a randomized open label design. All subjects will undergo a screening visit; if inclusion and exclusion criteria are fulfilled they will be enrolled in the study. At the time of enrollment the subject will continue their home insulin regimen and will be randomized to an add an oral hypoglycemic agent(s) : metformin, sitagliptin or combination therapy (metformin and sitagliptin). The total duration on study medication will be 6 weeks. All subjects will undergo a baseline mixed meal tolerance test (MMTT) in their standard or usual insulin Each subject will undergo a total of two studies. Blood draws will be necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 13 to 18 years\n* HbA1c \\>7.5% but \\<10%\n* Subjects must be on intensive insulin management\n* Tanner stage greater than or equal to 4\n* Must have T1DM for at least one year , T1DM defined by ADA criteria and having at least one of the following antibodies: Anti-GAD, Anti-islet, Anti-insulin\n* C-peptide \\> 0.6 ng/ml\n\nExclusion Criteria:\n\n* Type 2 diabetes\n* History of any other chronic condition (except hypothyroidism stable on medications)\n* Actively taking medications that may affect glucose excursions (steroids or oral contraceptives)\n* Evidence of anemia, clinically significant elevation of the liver enzymes (3 X normal), amylase or lipase (2 X normal), abnormal triclycerides (3 X normal), abnormal renal function test\n* An unsupportive family environment and pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT01718093', 'briefTitle': 'A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'H-29924'}, 'secondaryIdInfos': [{'id': 'DK096067', 'type': 'OTHER', 'domain': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin plus sitagliptin', 'description': 'The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily', 'interventionNames': ['Drug: Sitagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin plus metformin', 'description': 'The subjects continued their usual insulin regimen throughout the study. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated.', 'interventionNames': ['Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin plus sitagliptin and metformin', 'description': 'The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated.', 'interventionNames': ['Drug: Sitagliptin + Metformin']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia'], 'description': 'up to 50 mg twice a day', 'armGroupLabels': ['Insulin plus sitagliptin']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'up to 1000 mg twice a day', 'armGroupLabels': ['Insulin plus metformin']}, {'name': 'Sitagliptin + Metformin', 'type': 'DRUG', 'otherNames': ['Sitagliptin + Metformin = Janumet'], 'description': 'up to 50/1000 mg twice a day', 'armGroupLabels': ['Insulin plus sitagliptin and metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Luisa M. Rodriguez, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor - Department of Pediatrics - Endocrinology and Metabolism', 'investigatorFullName': 'Luisa M. Rodriguez', 'investigatorAffiliation': 'Baylor College of Medicine'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-12-04', 'type': 'RELEASE'}, {'date': '2020-12-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Luisa M. Rodriguez, Assistant Professor - Department of Pediatrics - Endocrinology and Metabolism, Baylor College of Medicine'}}}}