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

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.