| Trial ID: | L7281 |
| Source ID: | NCT00099853
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Vildagliptin|DRUG: pioglitazone|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c after 24 weeks | Secondary: Change from baseline in fasting plasma glucose at 24 weeks|Patients with endpoint HbA1c <7% after 24 weeks|Patients with reduction in HbA1c >/= to 0.7% after 24 weeks|Adverse event profile after 24 weeks of treatment|Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
362
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2004-05
|
| Completion Date: |
2008-01
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-17
|
| Locations: |
Novartis Pharmaceuticals, East Hanover, New Jersey, 07936, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00099853
|
