| Trial ID: | L3258 |
| Source ID: | NCT00468039
|
| Associated Drug: |
Vildagliptin + Metformin
|
| Title: |
A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: vildagliptin + metformin
|
| Outcome Measures: |
Primary: glycosylated hemoglobin (HbA1c)at Baseline and week 24, 24 weeks | Secondary: HbA1c at Baseline and week 12, 12 weeks|Fasting plasma glucose test (FPG) at Baseline and week 24, 24 weeks|Weight at baseline and week 24, 24 weeks|Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks, 24 weeks|Safety assessed by monitoring and recording all adverse events, serious adverse events., 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
94
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-03-06
|
| Completion Date: |
2008-06-06
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-19
|
| Locations: |
Diabetes and Glandular Disease Research Associates, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00468039
|
