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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00236626 |
The purpose of this study is to investigate (1) the effect of topiramate on insulin sensitivity in overweight or obese patients with type 2 diabetes mellitus and (2) the safety of topiramate in type 2 diabetic patients. The study will also investigate the effect of topiramate on body weight, body fat, fat distribution, and metabolic control including both glucose and lipid levels.
Condition | Intervention | Phase |
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Diabetes Mellitus, Adult-Onset Obesity Diabetes Mellitus, Type 2 |
Drug: topiramate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 9 Month, Double-Blind, Placebo-Controlled Study With a Blinded Crossover Transition to Open-Label Extension, Evaluating the Safety and Effectiveness of Topiramate on Insulin Sensitivity in Overweight or Obese Type 2 Diabetes Patients |
Estimated Enrollment: | 40 |
Study Start Date: | April 2000 |
Estimated Study Completion Date: | May 2002 |
Topiramate is not approved for the treatment of obesity. This double-blind, placebo controlled study investigates the effect of topiramate on insulin sensitivity in overweight or obese patients with Type 2 Diabetes. After a screening phase, patients are randomized to receive either topiramate (96 milligrams[mg] twice daily) or placebo for 9 months in the double-blind phase. After 9 months, patients have the option to continue in the open-label phase and receive treatment with topiramate for 1 year. Patients in the placebo group then receive topiramate with dosage increasing gradually to 96 mg twice daily, with the option of increasing to 256 mg twice daily. Patients in the topiramate group continue with the maintenance dose received during the double-blind phase, with the option of increasing to 256 mg twice daily. Assessments of effectiveness made monthly include insulin sensitivity, body composition (as measured by computed tomography [CT]), body weight and Body Mass Index (BMI), waist and hip circumferences, fasting lipid profile, fasting glucose and hemoglobin type A1c (HbA1c) levels, and blood pressure. Safety evaluations, including incidence of adverse events, clinical laboratory results, vital signs, and electrocardiograms [ECGs]), are performed throughout the study. The study hypothesis is that topiramate will improve insulin sensitivity in type 2 diabetic patients and will be well tolerated.
Patients will be randomized to receive 192 mg/day (96mg twice daily) of topiramate, or placebo, per mouth for 9 months, with an option of topiramte treatment increasing to 256mg/day both groups during the extension period of 1 year.
Ages Eligible for Study: | 35 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR003715 |
Study First Received: | October 7, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00236626 |
Health Authority: | United States: Institutional Review Board |
Body Mass Index Sulfonylurea Adult-Onset Diabetes Mellitus Hypertension Insulin Resistance |
Hyperlipidemia Type 2 Diabetes Metabolic Syndrome Topiramate Obesity |
Obesity Hyperlipidemias Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Insulin Body Weight Signs and Symptoms |
Diabetes Mellitus, Type 2 Topiramate Nutrition Disorders Overnutrition Endocrinopathy Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Hypertension |
Anti-Obesity Agents Therapeutic Uses Physiological Effects of Drugs Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |