Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT00231660
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077236', 'term': 'Topiramate'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-06', 'studyFirstSubmitDate': '2005-09-30', 'studyFirstSubmitQcDate': '2005-10-03', 'lastUpdatePostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60).'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline or from enrollment to Week 60 in BMI and HRQOL measures; safety evaluations, such as adverse events and vital signs throughout study.'}]}, 'conditionsModule': {'keywords': ['Type 2 Diabetes', 'Obesity', 'Metformin', 'Hemoglobin A1c', 'Adult-Onset Diabetes Mellitus (AODM)'], 'conditions': ['Obesity', 'Diabetes Mellitus, Type 2', 'Diabetes Mellitus, Adult-Onset']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=538&filename=CR003718_CSR.pdf', 'label': 'A Study of the Efficacy and Safety of Topiramate in the Treatment of Obese, Type 2 Diabetic Patients Treated with Metformin'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy (in terms of weight and hemoglobin type A1c \\[HbA1c\\]) and safety of topiramate (96 milligrams\\[mg\\] or 192 mg daily) with placebo in the treatment of obesity in Type 2 diabetic patients receiving metformin.', 'detailedDescription': 'Topiramate is not approved for the treatment of obesity. This double-blind, placebo-controlled study is designed to assess the efficacy and safety of topiramate in Type 2 diabetic patients with obesity who are well-controlled on metformin alone. Patients are randomized to receive either topiramate (up to a target dose of 96 or 192 mg per day) or placebo for one year. Assessments of efficacy include weight reduction, levels of HbA1c (shows average blood sugar level over a few months), Body Mass Index (BMI), and Health Related Quality of Life (HRQOL) measures. Safety evaluations (incidence of adverse events, vital signs, hypoglycemic events, electrocardiograms \\[ECGs\\], clinical laboratory values) are monitored throughout the study. The study hypothesis is that topiramate, combined with metformin and non-pharmacologic therapy, can effectively achieve significant weight reduction and is well tolerated. During the first 8 weeks, oral doses of matching placebo or topiramate are increased gradually to target dose (96 milligrams\\[mg\\] or 192mg daily); the dose will be maintained for 1 year, then gradually reduced and stopped'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Type 2 diabetes and receiving metformin monotherapy for at least the previous 4 months and on a stable daily dose for at least 2 months prior to enrollment\n* Metformin total daily dose not to exceed 2.1 grams/day\n* Body Mass Index \\>= 27 and \\< 50\n* HbA1c \\< 11%\n* Fasting plasma glucose \\>= 126 and \\< 240\n* Stable weight\n* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, or practicing an acceptable method of contraception (requires negative pregnancy test)\n\nExclusion Criteria:\n\n* Known contraindication, or hypersensitivity to topiramate\n* Use of other antidiabetic medications within the last 4 months\n* Excessive weight loss\n* Diagnosis of type 1 diabetes\n* History of severe or recurrent hypoglycemic episodes\n* Severe pulmonary disease'}, 'identificationModule': {'nctId': 'NCT00231660', 'briefTitle': 'A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Topiramate in the Treatment of Obese, Type 2 Diabetic Patients Treated With Metformin', 'orgStudyIdInfo': {'id': 'CR003718'}}, 'armsInterventionsModule': {'interventions': [{'name': 'topiramate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}}}}