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OpenTrials
Completed

NCT Number: NCT00099957

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Pharmaceuticals

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. Postprandial serum total triglycerides at 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Dec 22, 2004
Registry last updated
May 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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