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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: | NCT00231530 |
The purpose of this study is to determine the efficacy and safety of topiramate compared with placebo in obese, Type 2 diabetic patients on a controlled diet.
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, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetic Patients on a Controlled Diet |
Estimated Enrollment: | 600 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | May 2002 |
Topiramate is not approved for the treatment of obesity. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of topiramate in obese, diet-controlled, type 2 diabetic patients. Patients are randomized to receive either topiramate or placebo. After a 5 week pre-enrollment phase followed by a 6 week run-in phase, patients in the topiramate group start an 8-week titration phase to reach the assigned dose of topiramate, either 96 or 192 mg daily. Treatment continues for 1 year. Assessments of effectiveness include percent change in body weight, hemoglobin type A1c [HbA1c] levels, Body Mass Index [BMI], the numbers and proportion of 5% and 10% weight loss responders, glucose tolerance, waist and hip circumferences, changes in the mass of left ventricle of the heart, blood pressures, and fasting lipid profiles. Safety evaluations, including incidence of adverse events, vital signs, clinical laboratory values, and electrocardiograms [ECGs], are monitored throughout the study. The study hypothesis is that topiramate, combined with controlled diet, will be effective in weight reduction and controlling blood sugar level and is well tolerated.
During the initial 8 weeks, the oral doses of either a matching placebo or topiramate will be gradually increased to the target doses (96 milligrams[mg] or 192mg daily); the dose will be maintained for 1 year.
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: | CR003712 |
Study First Received: | September 30, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00231530 History of Changes |
Health Authority: | United States: Institutional Review Board |
Adult-Onset Diabetes Mellitus(AODM) Diabetic Diet Obesity |
Hyperlipidemia Hypertension Type 2 Diabetes Mellitus |
Obesity Hyperlipidemias Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Neuroprotective Agents Body Weight Anti-Obesity Agents Signs and Symptoms |
Diabetes Mellitus, Type 2 Topiramate Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Anticonvulsants Hypertension |
Obesity Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Overweight Protective Agents Neuroprotective Agents Pharmacologic Actions Body Weight |
Anti-Obesity Agents Signs and Symptoms Therapeutic Uses Diabetes Mellitus, Type 2 Nutrition Disorders Topiramate Overnutrition Glucose Metabolism Disorders Central Nervous System Agents Anticonvulsants |