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

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00389415

CLAF237A1303E1

Details and patient eligibility

About

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.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)