Skip to main content
Clinical Trials/NCT01552018
NCT01552018
Completed
Phase 4

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

Oslo University Hospital1 site in 1 country12 target enrollmentMarch 2012

Overview

Phase
Phase 4
Intervention
Saxagliptin
Conditions
Coronary Artery Disease
Sponsor
Oslo University Hospital
Enrollment
12
Locations
1
Primary Endpoint
Inflammatory biomarkers
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
February 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Saxagliptin

Saxagliptin 5 mg/day

Intervention: Saxagliptin

Placebo

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

  • Gene expression of DPP-4 in adipose tissue and leukocytes(Change in expression level of DPP-4 from baseline to 3 months)

Study Sites (1)

Loading locations...

Similar Trials