Saxagliptin and Atherosclerosis (SAXATH)

University of Oslo (UIO)

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Diabetes Mellitus Type 2

Treatments: Drug: Saxagliptin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01552018

2011/773b (REK)

Details and patient eligibility

About

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).

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Saxagliptin

Active Comparator group

Description:

Saxagliptin 5 mg/day

Treatment:

Drug: Saxagliptin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo