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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Enrollment
- 211
- Primary Endpoint
- The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60).
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Metformin total daily dose not to exceed 2.1 grams/day
- •Body Mass Index \>= 27 and \< 50
- •HbA1c \< 11%
- •Fasting plasma glucose \>= 126 and \< 240
- •Stable weight
- •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)
Exclusion Criteria
- •Known contraindication, or hypersensitivity to topiramate
- •Use of other antidiabetic medications within the last 4 months
- •Excessive weight loss
- •Diagnosis of type 1 diabetes
- •History of severe or recurrent hypoglycemic episodes
- •Severe pulmonary disease
Outcomes
Primary Outcomes
The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60).
Secondary Outcomes
- 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.