| Trial ID: | L6249 |
| Source ID: | NCT00260156
|
| Associated Drug: |
Vildagliptin
|
| Title: |
A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: vildagliptin|DRUG: placebo
|
| Outcome Measures: |
Primary: Change from baseline in hyperglycemia and arginine-stimulated first phase insulin secretion at 52 weeks, 52 weeks | Secondary: Change from baseline in disposition index at 52 weeks, 52 weeks|Change from baseline in hyperglycemia and arginine stimulated second phase insulin secretion at 52 weeks, 52 weeks|Change in hyperglycemia-stimulated first phase insulin secretion at 52 weeks, 52 weeks|Change in hyperglycemia-stimulated second phase insulin secretion at 52 weeks, 52 weeks|Beta-cell function parameter derived from standard meal challenge, 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
59
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2005-11
|
| Completion Date: |
2008-12
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-17
|
| Locations: |
Novartis Pharmaceuticals, Basel, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT00260156
|
