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

Novartis530 enrolled

Overview

This is a 52-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously 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

530

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Only patients successfully completing study CLAF237A2309 are eligible * Written informed consent * Ability to comply with all study requirements Exclusion Criteria: * Premature discontinuation from CLAF237A2309 * Other protocol-defined exclusion criteria may apply

Locations (2)

Novartis Investigative Site

East Hanover, New Jersey, United States

Novartis Investigative site

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 52 weeks and 104 weeks

Change in fasting plasma glucose between 52 weeks and 104 weeks

Change from baseline in fasting plasma glucose at 104 weeks

Change from baseline in HOMA B at 104 weeks

Change in HOMA B between 52 weeks and 104 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.