Saxagliptin combined with additional oral antihyperglycaemic agents in drug‐naive diabetic patients with high glycosylated haemoglobin: A 24‐week, multicentre, randomized, open‐label, active parallel‐controlled group clinical trial in China ( SUCCESS )

Abstract Aim To assess the efficacy and safety of a dipeptidyl peptidase‐4 (DPP‐4) inhibitor combined respectively with three oral antihyperglycaemic agents in Chinese patients with newly diagnosed type 2 diabetes mellitus (T2DM) with high levels of glycated haemoglobin (HbA1c). Materials and methods Between 30 December 2014 and 1 November 2017, a 24‐week, multicentre, parallel‐controlled study was performed on drug‐naive T2DM patients. In total, 648 patients with 8.0% ≤ HbA1c ≤ 11.0%, aged 18‐80 years and body mass index (BMI) 19‐40 kg/m 2 were randomly assigned 1:1:1 to receive saxagliptin (Saxa) combined with metformin (Met), acarbose (Aca) or gliclazide (Gli) modified release (MR) tablets (Saxa + Met, Saxa + Aca and Saxa + Gli). The primary outcome was the absolute change in HbA1c from baseline; secondary outcome was the percentage of patients achieving HbA1c <7.0% and ≤6.5%. Results Each treatment arm contained 216 patients; overall, 583 completed the 24‐week trial. At 24 weeks, the mean (95% confidence interval) change in HbA1c from baseline in Saxa + Met, Saxa + Aca and Saxa + Gli were, respectively: –2.9% [ – 3.1, – 2.8]; – 2.6% [ – 2.8, – 2.5]; and – 2.8% [–2.9, – 2.6] (overall p = .04, Saxa + Aca vs. Saxa + Met, p = .010, Saxa + Gli vs. Saxa + Met, p = 0.18). At 24 weeks, 84.9%, 74.7% and 80.3% of participants were at HbA1c <7.0% (overall p = .05); and 72.6%, 59.8% and 63.3% were HbA1c ≤6.5% (overall p = 0.10). The rates of minor or symptomatic hypoglycaemia were very low. Conclusions Initial treatment with a DPP‐4 inhibitor combined with Metform, alpha‐glycosidase inhibitor or sulphonylurea was safe and effective for patients with newly diagnosed T2DM and high HbA1c. DPP‐4 inhibitor combined with Met showed the best efficacy for this population.