Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

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

544 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-09-30

Brief Summary

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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 two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.

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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

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

Exclusion Criteria

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious 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