To Compare the Efficacy and Safey of Vildagliptin Compared to Voglibose in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00368134
• Lead Sponsor: Novartis

Brief Summary

This study is designed to evaluate the efficacy, safety and tolerability of vildagliptin compared to voglibose in patients with type 2 diabetes. Please note this study is not being conducted in the United States.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-23
• Study First Submitted QC: 2006-08-23
• Study First Posted: 2006-08-24
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-27
• Last Update Posted: 2007-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

• Diagnosis as Type 2 Diabetes
• Patients who have been placed on dietary therapy/exercise therapy, without achievement of glycemic control
• Outpatients

Exclusion Criteria

• Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
• Significant heart diseases
• Significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c after 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in FPG after 12 weeks
Change in Fasting Lipids after 12 weeks
Change in HOMA-IR after 12 weeks
Change in HOMA-B after 12 weeks
Safety Profile after 12 weeks treatment

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇯🇵 Tokyo, Japan