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

Novartis Pharmaceuticals3,118 enrolled

Overview

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 long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

3,118

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

glimepirideDRUG

MetforminDRUG

Vildagliptin matching placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 73 Years

Medical Language ↔ Plain English

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

Locations (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Investigative Centers

Nuremberg, Germany

Outcomes

Primary Outcomes

Time to HbA1c >8%

Time frame: 2 year

Secondary Outcomes

Change from baseline in HbA1c at 5 years

Time frame: 2 years (amended)

Adverse event profile after 5 years of treatment

Time frame: 2 years (amended)

Coefficient of failure for HbA1c from week 24 to 5 years

Time frame: 2 years (amended)

Change from baseline in fasting plasma glucose at 5 years

Time frame: 2 years (amended)

Change from baseline in body weight at 5 years

Time frame: 2 years (amended)

Data from ClinicalTrials.gov

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