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

Novartis

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Vildagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00380380

CLAF237A2378

Details and patient eligibility

About

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.

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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