| Trial ID: | L3748 |
| Source ID: | NCT00101712
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: vildagliptin|DRUG: Vildagliptin Placebo
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c at 52 weeks | Secondary: Adverse event profile after 52 weeks of treatment|Patients with HbA1c <6.5% at 12 weeks|Patients with HbA1c <6.5% at 52 weeks|Change from baseline in fasting plasma glucose at 52 weeks|Coefficient of failure for HbA1c between 24 weeks and 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
274
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2004-10
|
| Completion Date: |
2006-05
|
| Results First Posted: |
|
| Last Update Posted: |
2012-05-07
|
| Locations: |
Novartis Investigative Site, Investigative Site, Germany|Novartis Investigative Site, Basel, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT00101712
|
