| Trial ID: | L6536 |
| Source ID: | NCT00383578
|
| Associated Drug: |
Vildagliptin 100 Mg Qd
|
| Title: |
Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Vildagliptin 100 mg qd|DRUG: Metformin 1500 mg daily
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c, after 24 weeks of treatment | Secondary: Adverse event profile, after 24 weeks of treatment|Gastrointestinal tolerability, after 24 weeks of treatment|Patients with endpoint HbA1c <7% and patients with reduction in HbA1c > 0.7%, after 24 weeks of treatment|Change from baseline in fasting plasma glucose, after 24 weeks of treatment|Change from baseline in body weight, after 24 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
335
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-09
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-17
|
| Locations: |
Investigative Centers, Nurnberg, Germany|Novartis Pharmaceuticals, Basel, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT00383578
|
