Saxagliptin and Atherosclerosis (SAXATH)
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).
|Coronary Artery Disease Diabetes Mellitus Type 2||Drug: Saxagliptin Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Saxagliptin and Atherosclerosis. A Possible Role for Saxagliptin in the Prevention of Atherosclerosis Beyond Glucose Metabolism.|
- 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.
- Gene expression of DPP-4 in adipose tissue and leukocytes [ Time Frame: Change in expression level of DPP-4 from baseline to 3 months ]
|Study Start Date:||March 2012|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Saxagliptin
Saxagliptin 5 mg/day
Saxagliptin 5 mg, 1 tablet per day for 3 months
Other Name: Onglyza
Placebo Comparator: Placebo
Placebo, 1 tablet per day for 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552018
|Center for Clinical Heart Research, Dept. of Cardiology, Oslo University Hospital Ullevaal|
|Oslo, Norway, N-0424|
|Principal Investigator:||Ida U Njerve, MD||Center for Clinical Heart Research, Dept. of Cardiology, Oslo University Hospital Ullevaal, Norway|