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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: | NCT00231660 |
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.
Condition | Intervention | Phase |
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Diabetes Mellitus, Adult-Onset Obesity Diabetes Mellitus, Type 2 |
Drug: topiramate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 838 |
Study Start Date: | August 2000 |
Study Completion Date: | June 2002 |
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 evalutions (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
Ages Eligible for Study: | 18 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: | CR003718 |
Study First Received: | September 30, 2005 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00231660 History of Changes |
Health Authority: | United States: Institutional Review Board |
Adult-Onset Diabetes Mellitus (AODM) Metformin Obesity Hemoglobin A1c Type 2 Diabetes |
Obesity Metabolic Diseases Metformin Diabetes Mellitus Endocrine System Diseases Overweight Neuroprotective Agents Body Weight Anti-Obesity Agents Signs and Symptoms |
Hypoglycemic Agents Diabetes Mellitus, Type 2 Topiramate Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Anticonvulsants |
Obesity Metabolic Diseases Physiological Effects of Drugs Metformin Diabetes Mellitus Endocrine System Diseases Overweight Protective Agents Neuroprotective Agents Pharmacologic Actions Body Weight |
Anti-Obesity Agents Signs and Symptoms Hypoglycemic Agents Therapeutic Uses Diabetes Mellitus, Type 2 Nutrition Disorders Topiramate Overnutrition Glucose Metabolism Disorders Central Nervous System Agents Anticonvulsants |