A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin
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.
Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60).
- 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.
|Study Start Date:||October 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 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
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|