| Trial ID: | L2197 |
| Source ID: | NCT00101673
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: vildagliptin
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c at 12 weeks | Secondary: Adverse event profile after 12 weeks of treatment|Patients with reduction in HbA1c >/= 0.7% after 12 weeks|Change from baseline in fasting plasma glucose at 12 weeks|Change from baseline in HOMA-B at 12 weeks|Change from baseline in body weight at 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
251
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-03
|
| Completion Date: |
2005-06
|
| Results First Posted: |
|
| Last Update Posted: |
2012-05-07
|
| Locations: |
Novartis Pharmaceuticals, Basel, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT00101673
|
