A Study to Evaluate the Effect of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes

NCT ID: NCT00351585

Last Updated: 2012-05-07

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-09-30

Brief Summary

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Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.

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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Vildagliptin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with type 2 diabetes for at least 6 months
* Patients whose diabetes is controlled by diet and exercise only or patients taking metformin
* BMI in the range 22-45
* Blood glucose criteria must be met

Exclusion Criteria

* Pregnancy or lactation
* Type 1 diabetes or diabetes resulting from pancreatic injury
* Cardiovascular complications as defined by the protocol
* Significant diabetic complications as defined by the protocol
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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David D'Alessio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

References

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D'Alessio DA, Denney AM, Hermiller LM, Prigeon RL, Martin JM, Tharp WG, Saylan ML, He Y, Dunning BE, Foley JE, Pratley RE. Treatment with the dipeptidyl peptidase-4 inhibitor vildagliptin improves fasting islet-cell function in subjects with type 2 diabetes. J Clin Endocrinol Metab. 2009 Jan;94(1):81-8. doi: 10.1210/jc.2008-1135. Epub 2008 Oct 28.

Reference Type DERIVED
PMID: 18957505 (View on PubMed)

Other Identifiers

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CLAF237A2344

Identifier Type: -

Identifier Source: org_study_id

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