Diabetes Mellitus, Type 2
Conditions
Keywords
Vildagliptin, Type 2 diabetes
Brief summary
Please note this study is not being conducted in the United States. The purpose of this study is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.
Interventions
DRUGVildagliptin
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Inclusion criteria
* Must be able to complete a 3-week wash-out of current anti-diabetic medication * Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose * Must discontinue beta-blockers and lipid lowering drugs * Blood glucose criteria must be met * BMI in the range 30-35
Exclusion criteria
* History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes * Need for insulin within 3 months or patients on thiazolidinediones * Patients taking a sulfonylurea or metformin who cannot safely discontinue medication for the duration of the study * Significant concomitant disease or complications of diabetes * Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons * High tryglycerides as defined by the protocol * Smokers who cannot abstain from smoking during the treatment periods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To explore whether vildagliptin augments insulin mediated inhibition of adipose tissue lipid mobilization following a mixed meal in patients with type 2 diabetes | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure the effects of vildagliptin on tissue carbohydrate metabolism (skeletal muscle) | — |
Countries
Germany, United States
Outcome results
None listed