A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00099957
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study was not conducted in the United States. Many people with type 2 diabetes also have high cholesterol levels. The purpose of this study was to evaluate the effects of vildagliptin, an unapproved drug, on blood lipid measures such as triglycerides and cholesterol in people with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2004-12-21
• Study First Submitted QC: 2004-12-21
• Study First Posted: 2004-12-22
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-01
• Last Update Posted: 2012-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Blood glucose criteria must be met
• Genetic markers associated with increased risk of cardiovascular disease
• Not currently on drug therapy for type 2 diabetes
• Body mass index (BMI) in the range 25-40

Exclusion Criteria

• Pregnancy or lactation
• Type 1 diabetes
• High cholesterol as defined by the protocol
• Evidence of serious diabetic complications
• Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postprandial serum total triglycerides at 4 weeks

Secondary Outcome Measures

Name	Time	Method
Postprandial total cholesterol at 4 weeks
Postprandial total apo B at 4 weeks
Postprandial triglycerides in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
Postprandial cholesterol in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
Postprandial apo B-48 and apo B-100 in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland