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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin to Placebo as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325117
• Other study ID #: CLAF237A1302
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2006
• Last updated: May 10, 2007
• Start date: April 2006

Study information

• Verified date: May 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Vildagliptin

Locations

Country	Name	City	State
Japan	Novartis Pharmaceuticals	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to endpoint on HbA1c at 12 weeks
Secondary	Change from baseline to endpoint on fasting plasma glucose at 12 weeks
Secondary	Change from baseline to endpoint in HOMA B at 12 weeks
Secondary	Change from baseline to endpoint in HOMA IR at 12 weeks
Secondary	Change from baseline to endpoint on fasting lipids at 12 weeks
Secondary	Adverse events profile after 12 weeks of treatment