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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00380445

Run by

Novartis

People needed

21

Starts

2006-01-01

Expected to finish

2007-04-01

Last updated by the study team

2017-02-23

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States
• Novartis Investigative Site — Investigative Centers, Germany

Full record on ClinicalTrials.gov

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