Coronary Artery Disease, Diabetes Mellitus Type 2
Conditions
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).
Interventions
DRUGSaxagliptin
Saxagliptin 5 mg, 1 tablet per day for 3 months
DRUGPlacebo
Placebo, 1 tablet per day for 3 months.
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory biomarkers | 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
| Measure | Time frame |
|---|---|
| Gene expression of DPP-4 in adipose tissue and leukocytes | Change in expression level of DPP-4 from baseline to 3 months |
Countries
Norway
Outcome results
None listed