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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00099905
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this study is to assess the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo 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: 2004-04
• Study First Submitted: 2004-12-21
• Study First Submitted QC: 2004-12-21
• Study First Posted: 2004-12-22
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-01
• Last Update Posted: 2012-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 639

Inclusion Criteria

• Body mass index (BMI) in the range 22-45
• Blood glucose criteria must be met
• Not currently on drug therapy for type 2 diabetes

Exclusion Criteria

• Type 1 diabetes
• Evidence of serious 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 fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks
Patients with reduction in HbA1c>/=to 0.7% after 24 weeks
Change from baseline in body weight at 24 weeks
Change from baseline in fasting lipids at 24 weeks

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States