Diabetes Mellitus, Type 2
Conditions
Keywords
Vildagliptin, type 2 diabetes, gastric emptying
Brief summary
Please note this study is not being conducted in the United States. The purpose of this study is to assess the acute effects of vildagliptin, an unapproved drug, in reducing post-meal glucose levels by delaying gastric emptying.
Interventions
DRUGVildagliptin
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Inclusion criteria
* Must be able to complete a 1-week wash-out of current anti-diabetic medications * Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose * Blood glucose criteria must be met * BMI \<40
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 * Significant concommitant disease or complications of diabetes * Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons * Abnormal liver function tests as defined by the protocol * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the effects of acute effects of vildagliptin on gastric emptying | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in fasting and postprandial glucose levels. | — |
| Change in glucagon secretion | — |
| Effect on steady state levels of active GLP-1 and GIP | — |
| Effect on gastric peristalsis | — |
| Effect on satiety | — |
| Change in postprandial glucose kinetics | — |
Countries
Germany
Outcome results
None listed