| Trial ID: | L5848 |
| Source ID: | NCT00300287
|
| Associated Drug: |
Vildagliptin
|
| Title: |
A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Vildagliptin
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c at 108 weeks | Secondary: Adverse event profile after 108 weeks of treatment|Change in HbA1c from week 52 to week 108|Change from baseline in fasting plasma glucose at week 108|Change in fasting plasma glucose from week 52 to week 108|Change from baseline in body weight at week 108
|
| Sponsor/Collaborators: |
Sponsor: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
150
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-02-20
|
| Completion Date: |
2007-06-26
|
| Results First Posted: |
|
| Last Update Posted: |
2017-08-02
|
| Locations: |
Investigative Sites, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00300287
|
