Status:
COMPLETED
A Study of the Safety and Effectiveness of Topiramate on Insulin Sensitivity in Overweight or Obese Patients With Type 2 Diabetes
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Obesity
Diabetes Mellitus, Type 2
Eligibility:
All Genders
35-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate (1) the effect of topiramate on insulin sensitivity in overweight or obese patients with type 2 diabetes mellitus and (2) the safety of topiramate in type 2...
Detailed Description
Topiramate is not approved for the treatment of obesity. This double-blind, placebo controlled study investigates the effect of topiramate on insulin sensitivity in overweight or obese patients with T...
Eligibility Criteria
Inclusion
- Patients must have a history of Type 2 diabetes for 6 months, treated either by diet alone or by sulfonylurea for at least 6 months
- Hemoglobin A1c between 6.5% and 10%
- BMI between 27 and 50
- Non-smokers
- Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception
Exclusion
- Unstable endocrine disease
- Significantly abnormal liver function or kidney functions
- History of schizophrenia, major depressive disorder or eating disorder
- History of epilepsy, kidney stones or substance (alcohol) abuse
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2002
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00236626
Start Date
April 1 2000
End Date
May 1 2002
Last Update
June 8 2011
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