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 range
18 Years – 75 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.