A Study to Assess the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00380380
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Evaluate the effects of acute effects of vildagliptin on gastric emptying
- Secondary Outcome Measures
Name Time Method Change in glucagon secretion Effect on steady state levels of active GLP-1 and GIP Change in fasting and postprandial glucose levels. Change in postprandial glucose kinetics Effect on gastric peristalsis Effect on satiety
Trial Locations
- Locations (1)
Munich, 81377, Germany
🇩🇪Munich, Germany