A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00231530

Collaborator

(none)

541

Enrollment

15.9

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Obesity Diabetes Mellitus, Type 2 Diabetes Mellitus, Adult-Onset	Drug: topiramate	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

541 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2001

Actual Study Completion Date :

May 1, 2002

Outcome Measures

Primary Outcome Measures

The percent change in body weight and change in Hemoglobin A1c from enrollment to Week 60. []

Secondary Outcome Measures

Change from enrollment or baseline to Week 60 in BMI, waist circumference, glucose tolerance, lipid profile; safety measures, such as adverse events, throughout 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 >= 27 and < 50
Diagnosis of Type 2 diabetes according to either Swedish guideline or the American Diabetes Association (ADA) criteria
HbA1c <10.5% at enrollment
No previous oral antidiabetic medication or insulin therapy
Stable body weight
Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

Known contraindication or hypersensitivity to topiramate
Fasting plasma glucose (FPG) >= 13.1 millimolesl/liter (240 milligrams/deciliter) at baseline, Visit 4 (Week 0)
HBA1c of >10.5% at enrollment
History of severe recurrent hypoglycemic episodes prior to study entry
Use of any systemic corticosteroids within 30 days of enrollment
Diagnosed Type 1 diabetes
History of significant cardiovascular disease, uncontrolled thyroid disease, or kidney stones

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.