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

NCT ID: NCT00380445

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-04-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Vildagliptin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Novartis Investigative Site

Investigative Centers, , Germany

Site Status

Countries

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United States Germany

References

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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 Metab. 2009 Mar;94(3):846-52. doi: 10.1210/jc.2008-1400. Epub 2008 Dec 16.

Reference Type RESULT
PMID: 19088168 (View on PubMed)

Other Identifiers

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CLAF237A2379

Identifier Type: -

Identifier Source: org_study_id

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