Saxagliptin and Atherosclerosis

Coronary Artery Disease Clinical Trial

— SAXATH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552018
• Other study ID #: 2011/773b (REK)
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2012
• Last updated: June 17, 2014
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Myocardial Ischemia

Intervention

Drug:
• Saxagliptin
Saxagliptin 5 mg, 1 tablet per day for 3 months
• Placebo
Placebo, 1 tablet per day for 3 months.

Locations

Country	Name	City	State
Norway	Center for Clinical Heart Research, Dept. of Cardiology, Oslo University Hospital Ullevaal	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory biomarkers	A selection of biomarkers associated with atherosclerosis, circulating levels and gene expression levels in adipose tissue and leukocytes.	Changes in biomarkers from baseline to 3 months	No
Secondary	Gene expression of DPP-4 in adipose tissue and leukocytes		Change in expression level of DPP-4 from baseline to 3 months	No