A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00238498
• Lead Sponsor: Novartis

Brief Summary

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-30
• Last Update Posted: 2012-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

• Diagnosis of type 2 diabetes
• Patients who have been placed on diet and exercise therapy without achievement of glycemic control
• Outpatients

Exclusion Criteria

• Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
• Significant cardiovascular diseases
• Significant diabetic complications
• Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in HOMA B at 12 weeks
Change from baseline for postprandial glucose at 12 weeks
Change from baseline on fasting plasma glucose at 12 weeks
Change from baseline on postprandial glucose AUC at 12 weeks
Change from baseline in HOMA IR at 12 weeks