| Trial ID: | L6688 |
| Source ID: | NCT00102388
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: vildagliptin|DRUG: Gliclazide
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c at 104 weeks, 104 weeks | Secondary: Adverse event profile at 104 weeks, 104 weeks|Change from baseline in fasting plasma glucose at 104 weeks, 104 weeks|Patients with endpoint HbA1c <7% after 104 weeks, 104 weeks|Patients with reduction in HbA1c >/= 0.7% after 104 weeks, 104 weeks|Patients with reduction in HbA1x >/= 0.5% after 104 weeks, 104 weeks
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
1092
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2005-01
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-18
|
| Locations: |
Novartis Investigative Site, Investigative Centers, Germany|Novartis Pharmaceuticals, Basel, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT00102388
|
