A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin
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|ClinicalTrials.gov Identifier: NCT00231660|
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 :||211 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||October 2000|
|Actual Study Completion Date :||June 2002|
- 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.
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): NCT00231660
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|