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NCT00380445 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Effect of Vildagliptin on Adipose Tissue and Skeletal Muscle Metabolism in Obese Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00380445
Other study ID # CLAF237A2379
Secondary ID
Status Completed
Phase Phase 3
First received September 22, 2006
Last updated February 20, 2017
Start date January 2006
Est. completion date April 2007

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers
Gender All
Age group 30 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin

Locations
Country Name City State
Germany Novartis Investigative Site Investigative Centers
United States Novartis Pharmaceuticals East Hanover New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (1)

Boschmann M, Engeli S, Dobberstein K, Budziarek P, Strauss A, Boehnke J, Sweep FC, Luft FC, He Y, Foley JE, Jordan J. Dipeptidyl-peptidase-IV inhibition augments postprandial lipid mobilization and oxidation in type 2 diabetic patients. J Clin Endocrinol — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To explore whether vildagliptin augments insulin mediated inhibition of adipose tissue lipid mobilization following a mixed meal in patients with type 2 diabetes
Secondary To measure the effects of vildagliptin on tissue carbohydrate metabolism (skeletal muscle)
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