Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%

Novartis180 enrolled

Overview

This study is not being conducted in the United States. This is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range. 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

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Only patients successfully completing study CLAF237A2329 are eligible * Written informed consent * HbA1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units * Ability to comply with all study requirements Exclusion Criteria: * Premature discontinuation from study CLAF237A2329 * Other protocol-defined exclusion criteria may apply

Outcomes

Primary Outcomes

Safety in combination with pioglitizone after 52 weeks of treatment

Change from baseline in HbA1c at 52 weeks

Secondary Outcomes

Change from baseline in fasting plasma glucose at 52 weeks

Change from baseline in fasting lipids at 52 weeks

Change from baseline in body weight at 52 weeks

Change from baseline in HOMA B at 52 weeks

Change from baseline in HOMA IR at 52 weeks