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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00380445
• Collaborator: (none)
• Enrollment: 21
• Locations: 2
• Duration (Months): 14.9
• Patients Per Site: 10.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Effect of Vildagliptin on Adipose Tissue and Skeletal Muscle Metabolism in Obese Patients With Type 2 Diabetes
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

1. 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

1. To measure the effects of vildagliptin on tissue carbohydrate metabolism (skeletal muscle) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Pharmaceuticals	East Hanover	New Jersey	United States	07936
2	Novartis Investigative Site	Investigative Centers		Germany

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00380445
• Other Study ID Numbers: CLAF237A2379
• First Posted: Sep 26, 2006
• Last Update Posted: Feb 23, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Novartis: Vildagliptin, Type 2 diabetes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Vildagliptin

Study Results

No Results Posted as of Feb 23, 2017