Efficacy and Safety of Vildagliptin in Combination With Glimepiride 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

515 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-10-31

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, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea 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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LAF237 50 mg qd + glimepiride 4 mg qd

Group Type EXPERIMENTAL

vildagliptin

Intervention Type DRUG

Glimepiride

Intervention Type DRUG

Glimepiride 4 mg qd

LAF237 50 mg bid + glimepiride 4 mg qd

Group Type EXPERIMENTAL

vildagliptin

Intervention Type DRUG

Glimepiride

Intervention Type DRUG

Glimepiride 4 mg qd

LAF237 placebo + glimepiride 4 mg qd

Group Type PLACEBO_COMPARATOR

Glimepiride

Intervention Type DRUG

Glimepiride 4 mg qd

LAF237 placebo

Intervention Type DRUG

Interventions

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vildagliptin

Intervention Type DRUG

Glimepiride

Glimepiride 4 mg qd

Intervention Type DRUG

LAF237 placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Blood glucose criteria must be met
* Previously treated with a sulfonylurea for at least 3 months
* Body mass index (BMI) in the range 22-45

Exclusion Criteria

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious cardiovascular complications
* Evidence of serious diabetic complications
* Laboratory value abnormalities as defined by the protocol
* Known sensitivity to glimepiride

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No