To Assess the Efficacy and Safety of Vildagliptin as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy

Novartis

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Vildagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00325117

CLAF237A1302

Details and patient eligibility

About

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is designed as a multicenter, randomized, double-blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy.

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of type 2 diabetes and treated with a stable dose of sulfonylurea
Patients on diet and exercise who have not reached 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.