Study to Assess the Effect of 24 Weeks of Treatment With Vildagliptin in Patients With Type 2 Diabetes
The study will demonstrate the effect of 24 weeks of treatment with vildagliptin compared to placebo on insulin sensitivity in patients with type 2 diabetes mellitus (T2DM) treated with metformin, assessed as glucose Rd (rate of glucose disposal) during a hyperinsulinemic euglycemic clamp.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Single-center,Double-blind,Randomised,Placebo-controlled,Parallel-group Study to Assess the Effect of 24 Weeks of Treatment With Vildagliptin on Insulin Sensitivity and Its Underlying Mechanism in Patients With T2DM Treated With Metformin|
- Measure: effect of treatment on insulin sensitivity, assessed as glucose Rd (rate of glucose disposal). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Dosage 50mg b.i.d.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356381
|Novartis Investigative Site|
|Newcastle Upon Tyne, United Kingdom, NE4 5PL|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|