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Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

NCT ID: NCT00102466

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

1007 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-01-31

Brief Summary

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This study is not being conducted in the United States. Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

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

Metformin

Intervention Type DRUG

Gliclazide

Group Type ACTIVE_COMPARATOR

Gliclazide

Intervention Type DRUG

Metformin

Intervention Type DRUG

Interventions

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vildagliptin

Intervention Type DRUG

Gliclazide

Intervention Type DRUG

Metformin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* On a stable dose of metformin as defined by the protocol
* Blood glucose criteria must be met
* Body mass index (BMI) in the range 22-45

Exclusion Criteria

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of significant diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 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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Investigative Centers

Nuremberg, , Germany

Site Status

Novartis Pharmaceuticals

Basel, , Switzerland

Site Status

Countries

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Germany Switzerland

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2851

Results for CLAF237A2338 from the Novartis Clinical Trials website

Other Identifiers

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CLAF237A2338

Identifier Type: -

Identifier Source: org_study_id