A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

Novartis150 enrolled

Overview

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo 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 and whose blood glucose levels are close to normal.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Completion of study CLAF237A2307 within 4 weeks of entering into the extension * Written informed consent * Ability to comply with all study requirements * Blood glucose criteria must be met Exclusion Criteria: * Premature discontinuation from study CLAF237A2307

Outcomes

Primary Outcomes

Change from baseline in HbA1c at 108 weeks

Secondary Outcomes

Adverse event profile after 108 weeks of treatment

Change in HbA1c from week 52 to week 108

Change from baseline in fasting plasma glucose at week 108

Change in fasting plasma glucose from week 52 to week 108

Change from baseline in body weight at week 108