| Trial ID: | L4278 |
| Source ID: | NCT01565096
|
| Associated Drug: |
Metformin
|
| Title: |
Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type II
|
| Interventions: |
DRUG: Metformin|DRUG: Metformin|DRUG: Vildagliptin|DRUG: Glimepiride
|
| Outcome Measures: |
Primary: Postprandial increase in intact proinsulin levels in patient treated with Vildagliptin and Metformin compared to intact proinsulin levels in patients treated with Glimepiride and Metformin (Area under the curve 0-300 min), One year | Secondary: Fasting intact proinsulin levels, One year|Max postprandial intact proinsulin levels, One year|Retinal endothelial response to flicker light stimulation, One year|Mean 24h systolic and diastolic blood pressure, One year|Erythrocyte deformability, One year|E-selectin, One year|Change in body weight, One year|hsCRP, One year|HbA1c, One year|Fasting blood glucose, One year|Number of hypoglycemic events, One year|Adverse events, One year|Drug related adverse events, One year
|
| Sponsor/Collaborators: |
Sponsor: ikfe-CRO GmbH | Collaborators: Novartis Pharmaceuticals|IKFE Institute for Clinical Research and Development
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-11
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2012-03-28
|
| Locations: |
ikfe GmbH, Mainz, 55116, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01565096
|
