Diabetes Mellitus, Non-Insulin-Dependent
Conditions
Brief summary
Administration of the incretin hormone, Glucagon-Like-Peptide-1 (GLP-1), has been shown to enhance insulin secretion and suppress glucagon secretion in response to meal ingestion. In addition, GLP-1 also delays gastric emptying and has been shown to enhance gastric accommodation. These characteristics make GLP-1 an ideal therapy for type 2 diabetes (T2D). However, because of its rapid breakdown by dipeptidylpeptidase IV (DPP IV), GLP-1 has to be administered by continuous intravenous infusion. This would be a drawback in clinical usage. LAF237 is a synthetic inhibitor of DPP IV which has been shown to raise GLP-1 levels and potentiate meal-induced insulin secretion and glucagon suppression. However, the effects of LAF237 on gastric emptying and satiety are at present unknown. The investigators propose to study the effects of LAF237 on gastric emptying, gastric volume and satiety in patients with T2D in addition to examining the direct and indirect (mediated via insulin and glucagon) of this compound on postprandial glucose metabolism.
Interventions
DRUGLAF237 = vildagliptin
Sponsors
Novartis Pharmaceuticals
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes without microvascular or macrovascular complications treated with diet or up to 2 oral agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastric Emptying | — |
| Gastric accommodation | — |
| Satiety | — |
| Gastrointestinal Symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| Meal Appearance Rate | — |
| Glucagon Secretion | — |
| Glucose Disappearance | — |
| Endogenous Glucose Production | — |
| Insulin Secretion | — |
Countries
United States
Outcome results
None listed