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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00380445
• Lead Sponsor: Novartis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-09-22
• Study First Submitted QC: 2006-09-22
• Study First Posted: 2006-09-26
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
To explore whether vildagliptin augments insulin mediated inhibition of adipose tissue lipid mobilization following a mixed meal in patients with type 2 diabetes

Secondary Outcome Measures

Name	Time	Method
To measure the effects of vildagliptin on tissue carbohydrate metabolism (skeletal muscle)

Trial Locations

Locations (2)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States

Novartis Investigative Site; 🇩🇪 Investigative Centers, Germany