| Trial ID: | L1861 |
| Source ID: | NCT00396357
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Vildagliptin|DRUG: metformin
|
| Outcome Measures: |
Primary: Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment, 24 weeks | Secondary: Adverse event profile after 24 weeks of treatment, 24 weeks|Gastrointestinal tolerability after 24 weeks of treatment, 24 weeks|Patients with endpoint HbA1c <7% and <6.5% after 24 weeks, 24 weeks|Patients with reduction in HbA1c >0.7% after 24 weeks, 24 weeks|Change from baseline in fasting plasma glucose after 24 weeks, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
914
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-10
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-17
|
| Locations: |
Novartis Pharmaceuticals, East Hanover, New Jersey, 07936, United States|Novartis Investigative Site, Multiple Locations, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00396357
|
