| Trial ID: | L1897 |
| Source ID: | NCT00231660
|
| Associated Drug: |
Topiramate
|
| Title: |
A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Obesity|Diabetes Mellitus, Type 2|Diabetes Mellitus, Adult-Onset
|
| Interventions: |
DRUG: topiramate
|
| Outcome Measures: |
Primary: The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60). | Secondary: 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.
|
| Sponsor/Collaborators: |
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
211
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2000-10
|
| Completion Date: |
2002-06
|
| Results First Posted: |
|
| Last Update Posted: |
2011-06-08
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00231660
|
