CompletedPhase 3

A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin

211 participantsStarted 2000-10

Plain-language 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 of obesity in Type 2 diabetic patients receiving metformin.

Who can participate

Age range18 Years – 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: * 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 Criteria: * 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

What they're measuring

The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60).

Trial details

NCT IDNCT00231660

SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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