A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin

Phase 3

Completed

• Conditions: Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset

• Registration Number: NCT00231660
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

Study Timeline

• Study Start: 2000-10
• Study Completion: 2002-06
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-04
• Status Verified: 2011-01
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60).

Secondary Outcome Measures

Name	Time	Method
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.