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NCT00099957 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00099957
Other study ID # CLAF237A2217
Secondary ID
Status Completed
Phase Phase 2
First received December 21, 2004
Last updated May 1, 2012
Start date September 2003
Est. completion date June 2005

Study information
Verified date May 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date June 2005
Est. primary completion date June 2005
Accepts healthy volunteers No
Gender Both
Age group 30 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• vildagliptin

Locations
Country Name City State
Switzerland Novartis Pharmaceuticals Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postprandial serum total triglycerides at 4 weeks
Secondary Postprandial total cholesterol at 4 weeks
Secondary Postprandial total apo B at 4 weeks
Secondary Postprandial triglycerides in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
Secondary Postprandial cholesterol in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
Secondary Postprandial apo B-48 and apo B-100 in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
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