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A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes

NCT ID: NCT00260156

Last Updated: 2020-12-17

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

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-12-31

Brief Summary

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This study is not being conducted in the United States. The purpose of this study is to assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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Type 2 diabetes vildagliptin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vildagliptin

Group Type EXPERIMENTAL

vildagliptin

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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vildagliptin

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Not currently on drug therapy for type 2 diabetes
* Blood glucose criteria must be met

Exclusion Criteria

* History of type 1 diabetes
* Evidence of significant diabetic complications
* Serious cardiovascular events within the past 6 months
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

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

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Foley JE, Bunck MC, Moller-Goede DL, Poelma M, Nijpels G, Eekhoff EM, Schweizer A, Heine RJ, Diamant M. Beta cell function following 1 year vildagliptin or placebo treatment and after 12 week washout in drug-naive patients with type 2 diabetes and mild hyperglycaemia: a randomised controlled trial. Diabetologia. 2011 Aug;54(8):1985-91. doi: 10.1007/s00125-011-2167-8. Epub 2011 May 6.

Reference Type DERIVED
PMID: 21547496 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2798

Results for CLAF237A2381 on the Novartis clinical trials website

Other Identifiers

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CLAF237A2381

Identifier Type: -

Identifier Source: org_study_id