A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Assess the Efficacy and Safety of Topiramate OROS Controlled-Release in the Treatment of Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin
1 other identifier
interventional
113
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of a topiramate controlled-release formulation in the treatment of obese, type 2 diabetic patients managed with diet alone or combined with metformin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 obesity
Started Feb 2004
Shorter than P25 for phase_2 obesity
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
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
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)
Percent change in body weight from baseline to Week 16.
Secondary Outcomes (1)
Changes in body weight, body mass index,anthropometric measurements (waste and hip circumference and their ratio),fasting blood glucose and lipid profile from baseline to Week 16; safety evaluations including incidence of adverse events during the study.
Interventions
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) \>= 27 kg/m\^2 and \<50 kg/m\^2
- Diagnosis of type 2 diabetes, managed with either diet alone or combined with monotherapy treatment with metformin
- Stable weight for at least 2 months
- Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test).
You may not qualify if:
- Contraindication or hypersensitivity to topiramate
- Exposure to any other experimental drug or device within past 90 days
- Established diagnosis of Type 1 diabetes
- History of severe or recurrent hypoglycemic episodes prior to study entry
- Taking oral antidiabetic medications other than metformin
- Treatment with insulin within 4 months
- Significant liver, kidney or cardiovascular diseases.
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 2
- 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
February 1, 2004
Study Completion
October 1, 2004
Last Updated
June 8, 2011
Record last verified: 2011-01