| Trial ID: | L5025 |
| Source ID: | NCT01426802
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: vildagliptin
|
| Outcome Measures: |
Primary: Evaluate the safety and tolerability of vildagliptin 50 mg bid, Efficacy of vildagliptin based on the reduction in mean HbA1c and mean fasting plasma glucose with vildagliptin treatment at 12 weeks. Safety is measured by monitoring lipids profile, liver and kidney function to assess vildagliptin safety., 12 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
150
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2010-10
|
| Completion Date: |
2011-04
|
| Results First Posted: |
|
| Last Update Posted: |
2017-02-27
|
| Locations: |
Investigative site, Cairo, Egypt
|
| URL: |
https://clinicaltrials.gov/show/NCT01426802
|
