A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patie⦠(NCT00231530) | Clinical Trial Compass
CompletedPhase 3
A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet
541 participantsStarted 2001-01
Plain-language 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.
Who can participate
Age range18 Years ā 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
The percent change in body weight and change in Hemoglobin A1c from enrollment to Week 60.
Trial details
NCT IDNCT00231530
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.