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
Sponsor study identifier
interventional
211
0 countries
N/A
Study Start
October 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
June 2002
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2002
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2000
Date type not reportedThis date has not been verified as actual or estimated.
June 2002
Actual (reported)September 30, 2005
Actual (reported)October 4, 2005
Actual (reported)The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
211 participants (actual enrollment reported by the registry).
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
October 2000
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Study Completion
June 2002
Actual (reported)Last Updated
June 8, 2011
Record last verified: 2011-01
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Source: ClinicalTrials.gov.
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