Effect of Vildagliptin on Fat and Muscle Metabolism in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00380445

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Vildagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Effect of Vildagliptin on Adipose Tissue and Skeletal Muscle Metabolism in Obese Patients With Type 2 Diabetes

Further study details as provided by Novartis:

Primary Outcome Measures:

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:

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

Enrollment:	20
Study Start Date:	January 2006

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380445

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CLAF237A2379
Study First Received:	September 22, 2006
Last Updated:	May 3, 2007
ClinicalTrials.gov Identifier:	NCT00380445
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Vildagliptin, Type 2 diabetes

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Vildagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009