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

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.
ClinicalTrials.gov Identifier: NCT00099957
Recruitment Status : Completed
First Posted : December 22, 2004
Last Update Posted : May 2, 2012
Sponsor:
Information provided by:
Novartis

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: vildagliptin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters in Patients With Type 2 Diabetes
Study Start Date : September 2003
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Postprandial serum total triglycerides at 4 weeks

Secondary Outcome Measures :
  1. Postprandial total cholesterol at 4 weeks
  2. Postprandial total apo B at 4 weeks
  3. Postprandial triglycerides in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
  4. Postprandial cholesterol in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
  5. Postprandial apo B-48 and apo B-100 in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099957


Locations
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00099957     History of Changes
Other Study ID Numbers: CLAF237A2217
First Posted: December 22, 2004    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: May 2012

Keywords provided by Novartis:
type 2 diabetes
vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs