Efficacy and Safety of Vildagliptin in Combination With Insulin 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

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-06-30

Brief Summary

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Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin 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 insulin as defined by the protocol
* Body mass inde (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

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No