| Trial ID: | L5580 |
| Source ID: | NCT01099137
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Effect of Vildagliptin in Type 2 Diabetes Treated With Sulphonylurea and Metformin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes
|
| Interventions: |
DRUG: Vildagliptin|DRUG: Sulphonylurea dose-up
|
| Outcome Measures: |
Primary: The change of HbA1c, 24weeks | Secondary: Fasting Plasma Glucose (FPG), 24 weeks|Postprandial Plasma Glucose (PPG), 24 weeks|Hypoglycemia, 24 weeks|Body weight, 24 weeks|HbA1c < 7.0% without hypoglycemia, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Seoul National University Bundang Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
344
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-01
|
| Completion Date: |
2013-05
|
| Results First Posted: |
|
| Last Update Posted: |
2014-05-28
|
| Locations: |
Seoul National University Bundang Hospital, Seongnam, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01099137
|
