A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin
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
1 other identifier
interventional
211
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 obesity
Started Oct 2000
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedJune 8, 2011
January 1, 2011
September 30, 2005
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60).
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
October 1, 2000
Study Completion
June 1, 2002
Last Updated
June 8, 2011
Record last verified: 2011-01