Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00099892
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-12-21
• Study First Submitted QC: 2004-12-21
• Study First Posted: 2004-12-22
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 544

Inclusion Criteria

• Blood glucose criteria must be met
• On a stable dose of metformin as defined by the protocol
• Body mass index (BMI) in the range 22-45

Exclusion Criteria

• Type 1 diabetes
• Pregnancy or lactation
• Evidence of serious diabetic complications
• Evidence of serious cardiovascular complications
• 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 after 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