The Efficacy and Safety of Saxagliptin in Haemodialysis Patients

Abstract

Introduction: Good glycaemic control without causing excessive hypoglycaemia reduced the risk of macrovascular and microvascular complications in type 2 DM patients on regular haemodialysis (HD). The objectives of this study were to assess the efficacy and safety of add-on saxagliptin to insulin therapy in blood sugar control compared to insulin therapy alone in diabetic patients undergoing HD. Design and Methods: In this prospective open-labelled randomized controlled trial, HD patients with type 2 DM and on stable insulin therapy with HbA1c 7% - 13% were randomized to receive add-on saxagliptin 2.5 mg once daily to insulin therapy or insulin therapy only for 12 weeks. Results: 24 patients were randomized into each arm equally. Baseline and week-12 serum HbA1c, fructosamine, fasting blood glucose (FBS) and mean self monitoring blood glucose (SMBG) were comparable in the groups. Reduction of HbA1c and mean SMBG were significant in both groups. There was a significant drop in fructosamine levels (p = 0.004) and trend of lower FBS (p = 0.097) in add-on saxagliptin group but not in insulin alone group. The incidence of hypoglycaemia was the same in both groups. Conclusion: Add-on saxagliptin to insulin is comparable to insulin therapy alone in blood sugar control in regular HD patients and is safe and generally well tolerated. Add-on saxagliptin group may have more persistent and less fluctuation of glucose control compared to insulin only group.