Saxagliptin in combination with Metformin or Sulfonylurea achieved HbA1c goals

Diabetes affects over 1.2 million people in Australia. Saxagliptin (SAXA) is a potent, selective dipeptidyl peptidase-4 (DPP-4) inhibitor. Three 24-week phase 3 studies assessed efficacy and safety of SAXA as add-on to Metformin (MET), as initial combination therapy with MET, or as add-on to the sulfonylurea (SU) glyburide (GLY) in patients (pts) with type 2 diabetes (T2D) and inadequate glycaemic control. In the add-on to MET study, 743 pts inadequately controlled on MET alone (HbA1c 7.0%–10.0%; mean baseline (BL) HbA1c 8.0%; mean T2D duration 6.5 yrs) were randomised to SAXA or placebo (PBO) with ongoing dose of MET. In the initial combination study, 1306 drug naïve pts (HbA1c8.0%–12.0%; mean BL HbA1c 9.5%; mean T2D duration 1.7 yrs) were randomised to SAXA + MET, SAXA + PBO, or MET + PBO. In the add-on to SU study, 768 pts inadequately controlled on SU alone (HbA 1c7.5%–10.0%; mean BL HbA1c 8.4%; mean T2D duration 6.9 yrs) were randomised to SAXA or uptitrated GLY + PBO in addition to open-label GLY. Efficacy analyses used ANCOVA model. The proportion of patients reaching HbA1c goals used Fisher exact test. HbA1c goals were predefined for each study. In all three studies, statistically significantly greater proportions of SAXA-treated pts achieved HbA1c goals of <7.0% and ≤6.5% vs. control at 24 wks (Table). Twice as many pts treated with SAXA added to MET or GLY achieved the HbA1c goal of <7% and ≤6.5% relative to control at 24 wks. For all three studies, the frequency of adverse events (AEs) was generally similar for SAXA vs. control (Table). SAXA 5 mg + MET as either add-on or initial combination therapy, and SAXA 5 mg + SU significantly improved glycaemic control, was well tolerated and achieved predefined HbA1c goals vs. control in more patients