Long Term Safety of Vildagliptin (100mg qd) In Patients With Type 2 Diabetes

Novartis150 enrolled

Overview

This 52-week multicenter open-labeled extension study is designed to assess the long-term safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is open to patients who have completed core study CLAF237A1303.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis as Type 2 Diabetes * Patients who have completed study CLAF237A1303 * Outpatients Exclusion Criteria: * Patients who prematurely discontinued Study CLAF237A1303 * Other protocol-defined inclusion/exclusioncriterial may apply

Locations (1)

Novartis Pharmaceuticals

Tokyo, Japan

Outcomes

Primary Outcomes

Adverse events profile after 52 weeks of treatment

Secondary Outcomes

Change from baseline to endpoint on HbA1c at 52 weeks

Change from baseline to endpoint on fasting plasma glucose at 52 weeks

Change from baseline to endpoint in HOMA B at 52 weeks

Change from baseline to endpoint in HOMA IR at 52 weeks

Change from baseline to endpoint in body weight at 52 weeks

Data from ClinicalTrials.gov

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