| Trial ID: | L4746 |
| Source ID: | NCT01045590
|
| Associated Drug: |
Titration
|
| Title: |
Glibenclamide (Dose to be Titrated From Starting Dose of 5mg om) Plus Rosiglitazone 4mg om (Increased to 8mg om After 6 Months) and vs Glibenclamide (Dose to be Titrated With Starting Dose of 5mg om) Plus Placebo, Administered to Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: titration|DRUG: titration
|
| Outcome Measures: |
Primary: Change from baseline in the ratio (IAAT:SAT) between the intra-abdominal adipose tissue area (IAAT) and abdominal subcutaneous adipose tissue area [SAT] after 12 months treatment with oral glibenclamide plus rosiglitazone compared to oral glibenclamide p, baseline | Secondary: Comparisons will be made between glibenclamide plus rosiglitazone and glibenclamide plus placebo treatment groups on Change from baseline after 6 and 12 months treatment with respect the following, baseline
|
| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2003-12
|
| Completion Date: |
2006-02
|
| Results First Posted: |
|
| Last Update Posted: |
2012-06-18
|
| Locations: |
GSK Investigational Site, Seoul, 110-744, Korea, Republic of|GSK Investigational Site, Seoul, 120-752, Korea, Republic of|GSK Investigational Site, Seoul, 135-710, Korea, Republic of|GSK Investigational Site, Seoul, 137-701, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01045590
|
