| Trial ID: | L2398 |
| Source ID: | NCT00975065
|
| Associated Drug: |
Vildagliptin 50 Mg Bid Plus Metformin 1500mg (Galvus+Diabex)
|
| Title: |
Galvus on Met Phase 4 Study : Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)|DRUG: metformin 1500mg plus metformin 500mg or 1000mg (Diabex)
|
| Outcome Measures: |
Primary: Hemoglobin A1c at 24 weeks, 32weeks | Secondary: Hemoglobin A1c at 12 weeks, 32weeks|Fasting plasma glucose(Self Monitored Blood Glucose) at 24 week, 32weeks|2hours post-prandial plasma glucose(Self Monitored Blood Glucose) at 24 week, 32weeks|Fasting Lipid profiles at 24 week, 32weeks|Body weight at 24 week, 32weeks|Hypoglycemic events, Gastro-Intestinal events, other adverse events at each visit, 32weeks
|
| Sponsor/Collaborators: |
Sponsor: Handok Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
266
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-08
|
| Completion Date: |
2012-04
|
| Results First Posted: |
|
| Last Update Posted: |
2012-08-23
|
| Locations: |
Handok Pharmaceuticals, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT00975065
|
