Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, vildagliptin, glucagon, hypoglycemia
Brief summary
This mechanistic study is designed to investigate the effect of vildagliptin on the sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2 diabetes (T2DM).
Interventions
DRUGVildagliptin
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patients with T2DM, diagnosed at least 6 weeks prior to visit 1, who have had no treatment with oral antidiabetic agents for at least 12 weeks prior to study entry (visit 1) and no treatment with oral antidiabetic agents at any time in the past for \> 3 consecutive months * \>/= 18 years * Body mass index in the range of 22-35 kg/m2 * HbA1c \</=7.5%
Exclusion criteria
* Type 1 diabetes * Acute metabolic diabetic complications * Evidence of significant diabetic complications * Insulin treatment within the past 6 months Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucagon counterregulatory response to hypoglycemia assessed as glucagon Cmax of the 2.5 mM hypoglycemic clamp step after 4 weeks treatment | — |
| The 'insulin secretion rate relative to glucose' at the hypoglycemic clamp step after 4 weeks treatment | — |
| Change from baseline on hemoglobinA1c (HbA1c)and fasting plasma glucose | — |
| Safety based primarily on frequency of adverse events, number of notable abnormal laboratory values, and frequency and severity of hypoglycemic events | — |
Countries
Switzerland
Outcome results
None listed