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Completed

NCT Number: NCT01552018

Saxagliptin and Atherosclerosis

Dipeptidyl peptidase 4 (DPP-4) inhibitors are approved as add on therapy to improve glycaemic control in Type 2 Diabetes Mellitus (T2DM). DPP-4 inactivates the incretin hormone glucagon-like peptide 1 (GLP-1). Inhibiting the inactivation of GLP-1 leads to increased insulin- and reduced glucagon secretion after meals. DPP-4 has been shown to be present in atherosclerotic plaques. DPP-4 is a protease with substrates including cytokines and chemokines associated with atherosclerosis/inflammation.

The purpose of this study is to explore the effects of 3 months intervention with DPP-4 inhibitor saxagliptin on biomarkers related to atherosclerosis in patients with stable coronary artery disease (CAD) and T2DM, on circulating levels and on expression levels in circulating monocytes and adipose tissue.

A reduction in markers associated with atherosclerosis could indicate an antiatherosclerotic effect of DPP-4 inhibitors beyond glycaemic control alone.

Due to reduced sample size (recruitment problems) the main focus has changed and will now be on cellular aspects and gene regulation (initially secondary outcome measure).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center for Clinical Heart Research, Dept. of Cardiology, Oslo University Hospital Ullevaal

Oslo, N-0424, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients > 18, < 80 years old, with type 2 diabetes mellitus and angiographically proven coronary artery disease.
  • HbA1c > 6.5% and under treatment with either metformin and/or glimepiride.

Exclusion criteria

  • Allergy or hypersensitivity to any of the drug's components.
  • Heart failure in NYHA class III or IV.
  • Severe liver failure, moderate or severe kidney failure
  • Malignant disease.
  • Active infectious disease.
  • Acute coronary syndrome in the last 3 months.
  • Pregnancy or breastfeeding.

Treatment and study plan

Saxagliptin

Drug

Saxagliptin 5 mg, 1 tablet per day for 3 months

Other names: Onglyza

Placebo

Drug

Placebo, 1 tablet per day for 3 months.

Primary outcomes

  1. Inflammatory biomarkers

    Time frame: Changes in biomarkers from baseline to 3 months

    A selection of biomarkers associated with atherosclerosis, circulating levels and gene expression levels in adipose tissue and leukocytes.

Secondary outcomes

  1. Gene expression of DPP-4 in adipose tissue and leukocytes

    Time frame: Change in expression level of DPP-4 from baseline to 3 months

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Saxagliptin and Atherosclerosis. A Possible Role for Saxagliptin in the Prevention of Atherosclerosis Beyond Glucose Metabolism.

Acronym: SAXATH

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 13, 2012
Registry last updated
Jun 18, 2014

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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