| Trial ID: | L3344 |
| Source ID: | NCT00325117
|
| Associated Drug: |
Vildagliptin
|
| Title: |
To Assess the Efficacy and Safety of Vildagliptin as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Vildagliptin
|
| Outcome Measures: |
Primary: Change from baseline to endpoint on HbA1c at 12 weeks | Secondary: Change from baseline to endpoint on fasting plasma glucose at 12 weeks|Change from baseline to endpoint in HOMA B at 12 weeks|Change from baseline to endpoint in HOMA IR at 12 weeks|Change from baseline to endpoint on fasting lipids at 12 weeks|Adverse events profile after 12 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-04
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2007-05-14
|
| Locations: |
Novartis Pharmaceuticals, Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00325117
|
