Vascular and metabolic effects of ipragliflozin versus sitagliptin (IVS) in type 2 diabetes treated with sulphonylurea and metformin: IVS study

Abstract

AbstractObjectiveIn patients with type 2 diabetes who were inadequately controlled with metformin and sulphonylurea, we compared the glucose‐lowering efficacy, cardiometabolic parameters and safety of two drugs, ipragliflozin, a sodium‐glucose cotransporter‐2 inhibitor, and sitagliptin, a dipeptidyl peptidase‐4 inhibitor.Materials and MethodsPatients with 7.5%‐9.0% glycated haemoglobin treated with metformin and sulphonylurea were randomly assigned to ipragliflozin (50 mg, n = 70) or sitagliptin (100 mg, n = 70) therapy for 24 weeks. Measures of glycaemic control, fatty liver indices, other metabolic parameters and subclinical atherosclerosis were compared by a paired t‐test before and after 24 weeks of treatment.ResultsMean glycated haemoglobin levels decreased from 8.5% to 7.5% in the ipragliflozin group and from 8.5% to 7.8% in the sitagliptin group, resulting in a 0.34% between‐group difference (95% confidence interval, 0.10%‐0.43%, p = .088). Fasting and postprandial 2‐h glucose levels also showed a similar trend, with a greater reduction with ipragliflozin therapy. An increase of over 70% in ketone levels and a decrease in whole body and abdominal fat masses were observed with ipragliflozin treatment. Fatty liver indices also improved with ipragliflozin treatment. Despite no difference in carotid intima‐media thickness and ankle‐brachial index, ipragliflozin therapy improved flow‐mediated vasodilation, reflecting endothelial function, while sitagliptin did not. The safety profile did not differ between the two groups.ConclusionsIpragliflozin add‐on therapy can be a viable option for better glycaemic control with multiple vascular and metabolic benefits in patients with type 2 diabetes who are inadequately controlled with metformin and sulphonylurea.