Clinical trial NCT00231660: A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Topiramate in the Treatment of Obese, Type 2 Diabetic Patients Treated With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
Keywords: Type 2 Diabetes
Obesity
Metformin
Hemoglobin A1c
Adult-Onset Diabetes Mellitus (AODM)
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Topiramate is not approved for the treatment of obesity. This double-blind, placebo-controlled study is designed to assess the efficacy and safety of topiramate in Type 2 diabetic patients with obesity who are well-controlled on metformin alone. Patients are randomized to receive either topiramate (up to a target dose of 96 or 192 mg per day) or placebo for one year. Assessments of efficacy include weight reduction, levels of HbA1c (shows average blood sugar level over a few months), Body Mass Index (BMI), and Health Related Quality of Life (HRQOL) measures. Safety evaluations (incidence of adverse events, vital signs, hypoglycemic events, electrocardiograms \[ECGs\], clinical laboratory values) are monitored throughout the study. The study hypothesis is that topiramate, combined with metformin and non-pharmacologic therapy, can effectively achieve significant weight reduction and is well tolerated. During the first 8 weeks, oral doses of matching placebo or topiramate are increased gradually to target dose (96 milligrams\[mg\] or 192mg daily); the dose will be maintained for 1 year, then gradually reduced and stopped

Eligibility criteria: 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

Primary outcomes:
measure: The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60).
Secondary outcomes:
measure: Changes from baseline or from enrollment to Week 60 in BMI and HRQOL measures; safety evaluations, such as adverse events and vital signs throughout study.
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: