One‐year efficacy and safety of saxagliptin add‐on in patients receiving dapagliflozin and metformin

Aims Greater reductions in glycated haemoglobin (HbA1c) with saxagliptin, a dipeptidyl peptidase‐4 inhibitor, versus placebo add‐on in patients with type 2 diabetes who had inadequate glycaemic control with dapagliflozin 10 mg/d plus metformin were demonstrated after 24 weeks of treatment. Results over 52 weeks of treatment were assessed in this analysis. Materials and methods Patients (mean baseline HbA1c 7.9%) receiving open‐label dapagliflozin 10 mg/d plus metformin were randomized to double‐blind saxagliptin 5 mg/d or placebo add‐on. Results The adjusted mean change from baseline to week 52 in HbA1c was greater with saxagliptin than with placebo add‐on −0.38% vs 0.05%; difference −0.42% (95% confidence interval −0.64, −0.20)]. More patients achieved the HbA1c target of <7% with saxagliptin than with placebo add‐on (29% vs 13%), and fewer patients were rescued or discontinued the study for lack of glycaemic control with saxagliptin than with placebo add‐on (19% vs 28%). Reductions from baseline in body weight (≤1.5 kg) occurred in both groups. Similar proportions of patients reported ≥1 adverse event with saxagliptin (58.2%) and placebo add‐on (58.0%); no new safety signals were detected. Hypoglycaemia was infrequent in both treatment groups (≤2.5%), with no major episodes. The rate of urinary tract infections was similar in the saxagliptin and placebo add‐on groups (7.8% vs 7.4%). The incidence of genital infections was 3.3% with saxagliptin versus 6.2% with placebo add‐on. Conclusions Triple therapy with saxagliptin add‐on to dapagliflozin plus metformin for 52 weeks resulted in sustained improvements in glycaemic control without an increase in body weight or increased risk of hypoglycaemia.