| Trial ID: | L7044 |
| Source ID: | NCT00231647
|
| Associated Drug: |
Topiramate
|
| Title: |
A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Obesity|Diabetes Mellitus, Type 2|Diabetes Mellitus, Adult-Onset
|
| Interventions: |
DRUG: topiramate
|
| Outcome Measures: |
Primary: Percent change in body weight from baseline to Week 16. | Secondary: 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.
|
| Sponsor/Collaborators: |
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
113
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-02
|
| Completion Date: |
2004-10
|
| Results First Posted: |
|
| Last Update Posted: |
2011-06-08
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00231647
|
