| Trial ID: | L4977 |
| Source ID: | NCT00494884
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: vildagliptin
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c, 24 weeks | Secondary: Change from baseline in fasting plasma glucose, 24 weeks|Adverse event profiles including gastrointestinal tolerability and hypoglycemia, 24 weeks|Responder rates, 24 weeks|Change from baseline in insulin and proinsulin in a subgroup of patients, 24 weeks|Change in systolic and diastolic blood pressure, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-06
|
| Completion Date: |
2008-07
|
| Results First Posted: |
|
| Last Update Posted: |
2017-02-27
|
| Locations: |
Novartis Investigative Site, Bochum, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00494884
|
