| Trial ID: | L3412 |
| Source ID: | NCT00382096
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Vildagliptin|DRUG: Metformin|DRUG: Vildagliptin + Metformin
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c, At week 24 | Secondary: Change from baseline in fasting plasma glucose, At week 24|Percent of patients with endpoint HbA1c <7%, At week 24|Percent of patients with reduction in HbA1c >/=0.7%, At week 24|Adverse event profile after treatment, At week 24|Change from baseline in body weight, At week 24
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
1179
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-09
|
| Completion Date: |
2008-06-03
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-19
|
| Locations: |
Novartis Pharmaceuticals, East Hanover, New Jersey, 07936, United States|Multiple Locations, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00382096
|
