| Trial ID: | L6596 |
| Source ID: | NCT00138593
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: vildagliptin
|
| Outcome Measures: |
Primary: Safety in combination with pioglitizone after 52 weeks of treatment|Change from baseline in HbA1c at 52 weeks | Secondary: Change from baseline in fasting plasma glucose at 52 weeks|Change from baseline in fasting lipids at 52 weeks|Change from baseline in body weight at 52 weeks|Change from baseline in HOMA B at 52 weeks|Change from baseline in HOMA IR at 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
180
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-07
|
| Completion Date: |
2006-07
|
| Results First Posted: |
|
| Last Update Posted: |
2017-03-01
|
| Locations: |
Novartis Pharmaceuticals, Basel, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT00138593
|
