A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin
June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
211
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60).
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Secondary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2000
Study Completion (Actual)
June 1, 2002
Study Registration Dates
First Submitted
September 30, 2005
First Submitted That Met QC Criteria
October 3, 2005
First Posted (Estimate)
October 4, 2005
Study Record Updates
Last Update Posted (Estimate)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 6, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR003718
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