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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Metformin Comparator; Drug: vildagliptin

• Registration Number: NCT00099866
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin 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: 2004-01
• Study First Submitted: 2004-12-21
• Study First Submitted QC: 2004-12-21
• Study First Posted: 2004-12-22
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

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

Exclusion Criteria

• Type 1 diabetes
• Pregnancy or lactation
• 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

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin Comparator	-
Vildagliptin	vildagliptin	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c at 52 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in body weight at 52 weeks
Change from baseline in fasting plasma glucose at 52 weeks
Change from baseline in fasting lipids at 52 weeks
Adverse event profile after 52 weeks of treatment
Change from baseline in HOMA B at 52 weeks

Trial Locations

Locations (1)

Novartis investigative Site; 🇩🇪 Investigative Sites, Germany

Novartis investigative Site

🇩🇪Investigative Sites, Germany