Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00110240
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-05-04
• Study First Submitted QC: 2005-05-04
• Study First Posted: 2005-05-05
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 594

Inclusion Criteria

• Not currently on drug therapy for type 2 diabetes
• Body mass index (BMI) in the range 20-40
• Blood glucose criteria must be met

Exclusion Criteria

• Pregnancy or lactation
• Type 1 diabetes
• Evidence of significant diabetic complications
• Evidence of serious cardiovascular conditions
• Laboratory value abnormalities as defined by the protocol
• 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 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c at 24 weeks for subset of Chinese patients
Overall adverse event profile after 24 weeks of treatment
Gastrointestinal side effect profiles after 24 weeks of treatment
Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland