Overview

A Study to Assess the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.

Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Details
Lead Sponsor:
Novartis
Treatments:
Vildagliptin
Criteria
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