A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00231647

Collaborator

(none)

113

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of a topiramate controlled-release formulation in the treatment of obese, type 2 diabetic patients managed with diet alone or combined with metformin.

Condition or Disease	Intervention/Treatment	Phase
Obesity Diabetes Mellitus, Type 2 Diabetes Mellitus, Adult-Onset	Drug: topiramate	Phase 2

Detailed Description

Topiramate is not approved for the treatment of obesity. Studies have shown that an immediate release formulation of topiramate reduces body weight in obese patients with or without type 2 diabetes. A novel controlled-release formulation of topiramate using OROS® technology has the potential for better efficacy and safety in the treatment of obesity. This double-blind, placebo controlled study will evaluate the effectiveness and safety of the controlled-release formulation in the treatment of obese subjects with type 2 diabetes. The study consists of 2 screening visits, a baseline visit, 7-week titration phase (topiramate dose will be increased from 25mg daily to 175mg daily), 9-week maintenance phase, 2-week taper phase and a 2-week follow-up. Effectiveness will be evaluated by the percent change in body weight, body mass index, and anthropometric measurements (waist and hip circumferences and their ratio). Safety evaluations (incidence and severity of adverse events, physical measurements and clinical laboratory tests) will be conducted throughout the study. The study hypothesis is that topiramate 175 mg daily, when administered as the OROS® controlled-release formulation, is effective (in terms of percent reduction in body weight from baseline to week 16) and safe, as compared with placebo, in the treatment of obese, type 2 diabetic patients managed with either diet alone or combined with metformin. During the titration phase, topiramate (in the OROS® controlled-release formulation) will be gradually increased to 175mg daily by mouth, and the dose will be maintained for 9 weeks, and then slowly discontinued over 2 weeks.

Study Design

Study Type:

Interventional

Actual Enrollment :

113 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Assess the Efficacy and Safety of Topiramate OROS Controlled-Release in the Treatment of Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin

Study Start Date :

Feb 1, 2004

Actual Study Completion Date :

Oct 1, 2004

Outcome Measures

Primary Outcome Measures

Percent change in body weight from baseline to Week 16. []

Secondary Outcome Measures

Changes in body weight, body mass index,anthropometric measurements (waste and hip circumference and their ratio),fasting blood glucose and lipid profile from baseline to Week 16; safety evaluations including incidence of adverse events during the study. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Body Mass Index (BMI) >= 27 kg/m^{2 and <50 kg/m}2
Diagnosis of type 2 diabetes, managed with either diet alone or combined with monotherapy treatment with metformin
Stable weight for at least 2 months
Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test).

Exclusion Criteria:

Contraindication or hypersensitivity to topiramate
Exposure to any other experimental drug or device within past 90 days
Established diagnosis of Type 1 diabetes
History of severe or recurrent hypoglycemic episodes prior to study entry
Taking oral antidiabetic medications other than metformin
Treatment with insulin within 4 months
Significant liver, kidney or cardiovascular diseases.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.