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

• Status: Completed
• Trial end date: 2002-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Topiramate

Criteria

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