| Trial ID: | L1996 |
| Source ID: | NCT00396227
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: vildagliptin|DRUG: thiazolidinedione (TZD)
|
| Outcome Measures: |
Primary: Change from baseline in HemoglobinA1c (HbA1c), after 12 weeks of treatment | Secondary: Change from baseline in body weight, after 12 weeks of treatment|Change from baseline in fasting plasma glucose (FPG), after 12 weeks of treatment|Incidence of prespecified adverse events while on treatment with study drug, 12 week treatment duration
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
2665
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-10
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-18
|
| Locations: |
Novartis Pharmaceuticals, East Hanover, New Jersey, 07936, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00396227
|
