Status:
COMPLETED
A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Obesity
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 comb...
Detailed Description
Topiramate is not approved for the treatment of obesity. Studies have shown that an immediate release formulation of topiramate reduces body weight in obese patients with or without type 2 diabetes. A...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00231647
Start Date
February 1 2004
End Date
October 1 2004
Last Update
June 8 2011
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