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

Novartis Pharmaceuticals38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Postprandial serum total triglycerides at 4 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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