Effect of Vildagliptin on Fat and Muscle Metabolism in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2007-04-01
• 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 test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Vildagliptin

Criteria

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