Status:
COMPLETED
A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin
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 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...
Detailed Description
Topiramate is not approved for the treatment of obesity. This double-blind, placebo-controlled study is designed to assess the efficacy and safety of topiramate in Type 2 diabetic patients with obesit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2002
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00231660
Start Date
October 1 2000
End Date
June 1 2002
Last Update
June 8 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.