Diabetes Mellitus, Type 2
Conditions
Keywords
Vildagliptin, Type 2 diabetes, Insulin sensitivity, Insulin action
Brief summary
Type 2 diabetes results when the body does not produce enough insulin and/or is unable to properly use the insulin it makes (insulin resistance). This study was undertaken to assess the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.
Interventions
DRUGVildagliptin
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes at least 3 months prior to screening * Blood glucose criteria must be met * On stable dose of metformin therapy * BMI less than or equal to 39
Exclusion criteria
* Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes * Treatment with thiazolidinediones or use of insulin within the previous 3 months * Significant illness within 2 weeks prior to dosing * High fasting triglycerides as defined by the protocol Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect on insulin sensitivity at 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipolysis rate after 6 weeks of treatment | — |
| Plasma free fatty acid concentration after 6 weeks of treatment | — |
| Hepatic glucose production after 6 weeks of treatment | — |
| Glucose disposal after 6 weeks of treatment | — |
| Gluconeogenesis rate after 6 weeks of treatment | — |
Outcome results
None listed