Status:
TERMINATED
A Study of the Efficacy and Safety of Topiramate in Obese, Type 2 Diabetic Patients Inadequately Controlled on Sulfonylurea Therapy
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 effectiveness and safety of topiramate with placebo in the treatment of obesity and Type 2 diabetes mellitus in patients who have failed on sulfonylurea the...
Detailed Description
Topiramate is a medication for the treatment of seizures, but not approved for the treatment of obesity. This is a randomized, double-blind, placebo controlled study to evaluate the effectiveness and ...
Eligibility Criteria
Inclusion
- Diagnosis of Type 2 Diabetes, receiving only second generation sulfonylurea therapy (may include: glipizide, gliclazide, glimepiride, glibenclamide/glyburide, and gliquadone) for at least 4 months and on stable dose for at least 2 months
- Body Mass Index \>= 27 and \< 50
- HbA1c \< 11% at enrollment
- Diagnosed hypertension or hyperlipidemia must be controlled
- 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 or sulfonylurea therapy
- Pregnancy or women who are nursing or plan to become pregnant during the study
- Diagnosed with Type 1 diabetes
- History of severe or recurrent hypoglycemic episodes
- Treatment with any antidiabetic agent other than sulfonylurea
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2002
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00231634
Start Date
May 1 2001
End Date
November 1 2002
Last Update
June 8 2011
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