| Trial ID: | L3814 |
| Source ID: | NCT00106340
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: vildagliptin|DRUG: glimepiride|DRUG: Metformin|DRUG: Vildagliptin matching placebo|DRUG: Glimepiride matching placebo
|
| Outcome Measures: |
Primary: Time to HbA1c >8%, 2 year | Secondary: Change from baseline in HbA1c at 5 years, 2 years (amended)|Adverse event profile after 5 years of treatment, 2 years (amended)|Coefficient of failure for HbA1c from week 24 to 5 years, 2 years (amended)|Change from baseline in fasting plasma glucose at 5 years, 2 years (amended)|Change from baseline in body weight at 5 years, 2 years (amended)
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
3118
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2005-03
|
| Completion Date: |
2008-05-20
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-17
|
| Locations: |
Novartis Pharmaceuticals, East Hanover, New Jersey, 07936, United States|Investigative Centers, Nurnberg, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00106340
|
