Long-Term Safety Study of Vildagliptin 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

NCT00325429

CLAF237A1304

Details and patient eligibility

About

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 52-week clinical study is designed as an open label, long-term study aimed to evaluate the safety of vildagliptin in patients with type 2 diabetes.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of type 2 diabetes
• Patients who have been placed on diet and exercise therapy without achieving target blood glucose levels
• Outpatients

Exclusion criteria

• Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
• Significant cardiovascular complications as defined by the protocol
• Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)