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Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes

NCT ID: NCT00389415

Last Updated: 2008-11-27

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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This 52-week multicenter open-labeled extension study is designed to assess the long-term safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is open to patients who have completed core study CLAF237A1303.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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Type 2 Diabetes Vildagliptin HbA1c

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Vildagliptin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis as Type 2 Diabetes
* Patients who have completed study CLAF237A1303
* Outpatients

Exclusion Criteria

* Patients who prematurely discontinued Study CLAF237A1303
* Other protocol-defined inclusion/exclusioncriterial may apply
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CLAF237A1303E1

Identifier Type: -

Identifier Source: org_study_id