Status:
COMPLETED
A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Obesity
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Detailed Description
Topiramate is not approved for the treatment of obesity. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of topiramate in obese, diet-controlled, type ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2002
Estimated Enrollment :
541 Patients enrolled
Trial Details
Trial ID
NCT00231530
Start Date
January 1 2001
End Date
May 1 2002
Last Update
June 8 2011
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