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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00099957
First Posted: December 22, 2004
Last Update Posted: May 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
December 21, 2004
December 22, 2004
May 2, 2012
September 2003
June 2005   (Final data collection date for primary outcome measure)
Postprandial serum total triglycerides at 4 weeks
Hepatic metabolic correlates
Complete list of historical versions of study NCT00099957 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
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A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters in Patients With Type 2 Diabetes
A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters in Patients With Type 2 Diabetes
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: vildagliptin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
June 2005
June 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00099957
CLAF237A2217
Not Provided
Not Provided
Not Provided
Not Provided
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP