A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet
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|ClinicalTrials.gov Identifier: NCT00231530|
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Obesity Diabetes Mellitus, Type 2 Diabetes Mellitus, Adult-Onset||Drug: topiramate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||541 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetic Patients on a Controlled Diet|
|Study Start Date :||January 2001|
|Actual Study Completion Date :||May 2002|
- The percent change in body weight and change in Hemoglobin A1c from enrollment to Week 60.
- Change from enrollment or baseline to Week 60 in BMI, waist circumference, glucose tolerance, lipid profile; safety measures, such as adverse events, throughout study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231530
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|