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

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

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