Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

NCT ID: NCT00138619

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

478 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-04-30

Brief Summary

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This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

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

* Only patients successfully completing study CLAF237A2327 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria

* Premature discontinuation from study CLAF237A2327
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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

Investigative Centers, , Germany

Site Status

Countries

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United States Germany

References

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Rosenstock J, Niggli M, Maldonado-Lutomirsky M. Long-term 2-year safety and efficacy of vildagliptin compared with rosiglitazone in drug-naive patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 Jun;11(6):571-8. doi: 10.1111/j.1463-1326.2008.01021.x. Epub 2009 Apr 5.

Reference Type DERIVED
PMID: 19383032 (View on PubMed)

Other Identifiers

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CLAF237A2327E1

Identifier Type: -

Identifier Source: org_study_id

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