ONGLYZA® (saxagliptin)

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Study details: Scirica et al. 2013

This was a multi-centre, randomised, double-blind, placebo-controlled, phase 4 trial conducted at 788 sites in 26 countries.

Eligible patients had a history of documented type 2 diabetes, a HbA1c, of 6.5% to 12.0%, and either a history of established cardiovascular disease or multiple risk factors for vascular disease. To meet the criteria for established cardiovascular disease, patients had to be at least 40 years old and have a history of a clinical event associated with atherosclerosis involving the coronary, cerebrovascular, or peripheral vascular system. To meet the criteria for the multiple risk factors, patients had to be at least 55 years of age (men) or 60 years of age (women) with at least one of the following additional risk factors: dyslipidaemia, hypertension, or active smoking.

Eligible patients were randomly assigned (1:1 ratio), to receive saxagliptin at a dose of 5 mg daily (or 2.5 mg daily in patients with an estimated glomerular filtration rate [GFR] of ~50 ml per minute) or matching placebo. Stratification was according to the qualifying cardiovascular disease state (established cardiovascular disease vs. multiple risk factors only) and renal function (normal function or mild renal impairment [estimated GFR, >50 ml per minute] vs. moderate renal impairment [estimated GFR, 30 to 50 ml per minute] vs. severe renal impairment [estimated GFR, <30 ml per minute]). Patients in whom renal impairment (an estimated GFR of ~50 ml per minute) developed during the study period had a single dose adjustment to 2.5 mg daily.

The primary efficacy and safety end-point was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke.The secondary efficacy end-point included the primary composite end-point plus hospitalisation for heart failure, coronary revascularisation, or unstable angina.