A Study of the Efficacy and Safety of Topiramate in Obese, Type 2 Diabetic Patients Inadequately Controlled on Sulfonylurea Therapy

Obesity Clinical Trial

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 Inadequately Controlled on Sulfonylurea Therapy

Status Terminated

Clinical Trial Summary

The purpose of this study is to compare the effectiveness and safety of topiramate with placebo in the treatment of obesity and Type 2 diabetes mellitus in patients who have failed on sulfonylurea therapy.

Clinical Trial Description

Topiramate is a medication for the treatment of seizures, but not approved for the treatment of obesity. This is a randomized, double-blind, placebo controlled study to evaluate the effectiveness and safety of topiramate in Type 2 diabetic patients with obesity who have failed on treatment with sulfonylurea. After a 4-week enrollment phase and 8-week titration phase, patients receive either topiramate (96, 192, or 256 mg twice daily) or placebo for 44 weeks, followed by a 6-week follow-up phase. Assessments of effectiveness include body weight, hemoglobin type A1c [HbA1c] (a measurement of average blood sugar level over several months), Body Mass Index (BMI), fasting plasma glucose (FPG) level, fasting lipid profile, fasting insulin, uric acid level, blood pressures, and health related quality of life (HRQOL) measures. Safety evaluations, including incidence and severity of adverse events, hypoglycemic episodes, clinical laboratory results such as the liver enzymes, and vital signs, are performed throughout the study. The study hypothesis is that topiramate will be effective in the treatment of type 2 diabetes through weight reduction. During the initial 8-weeks, oral doses taken twice daily of topiramate or placebo will be gradually increased to target doses (either 96 milligrams[mg], 192mg, or 256mg daily); the dose will be maintained for 44 weeks. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Adult-Onset
• Diabetes Mellitus, Type 2
• Obesity

• NCT number: NCT00231634
• Study type: Interventional
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Status: Terminated
• Phase: Phase 3
• Start date: May 2001
• Completion date: November 2002