| Trial ID: | L5134 |
| Source ID: | NCT00351884
|
| Associated Drug: |
Vildagliptin Am
|
| Title: |
Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Vildagliptin AM|DRUG: vildagliptin pm|DRUG: placebo
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c at 24 weeks, 24 weeks | Secondary: Safety of vildagliptin in combination with metformin during 24 weeks of treatment, 24 weeks|Change from baseline in fasting plasma glucose at 24 weeks, 24 weeks|Patients with endpoint HbA1c < 7% after 24 weeks, 24 weeks|Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks, 24 weeks|Change from baseline in body weight at 24 weeks, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
370
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-05
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-18
|
| Locations: |
Novartis Pharmaceuticals, East Hanover, New Jersey, 07936, United States|Novartis Investigative Site, Investigative Centers, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00351884
|
