Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

Novartis478 enrolled

Overview

This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

478

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Only patients successfully completing study CLAF237A2327 are eligible * Written informed consent * Ability to comply with all study requirements Exclusion Criteria: * Premature discontinuation from study CLAF237A2327 * Other protocol-defined exclusion criteria may apply

Locations (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Unnamed facility

Investigative Centers, Germany

Outcomes

Primary Outcomes

Safety during 104 weeks of treatment

Change from baseline in HbA1c at 104 weeks

Secondary Outcomes

Change in HbA1c between 24 weeks and 104 weeks

Change from baseline in fasting plasma glucose at 104 weeks

Change in fasting plasma glucose between 24 weeks and 104 weeks

Change from baseline in HOMA B at 104 weeks

Change in HOMA B between 24 weeks and 104 weeks

Data from ClinicalTrials.gov

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