Effect of Vildagliptin on Fat and Muscle Metabolism 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

NCT00380445

CLAF237A2379

Details and patient eligibility

About

Please note this study is not being conducted in the United States. The purpose of this study is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.

Enrollment

21 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must be able to complete a 3-week wash-out of current anti-diabetic medication
Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose
Must discontinue beta-blockers and lipid lowering drugs
Blood glucose criteria must be met
BMI in the range 30-35

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
Patients taking a sulfonylurea or metformin who cannot safely discontinue medication for the duration of the study
Significant concomitant disease or complications of diabetes
Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons
High tryglycerides as defined by the protocol
Smokers who cannot abstain from smoking during the treatment periods