Efficacy of Saxagliptin versus Mitiglinid in patients with type 2 diabetes and end-stage renal disease

Abstract

Background: There are very few oral antidiabetic drugs recommended for patients on dialysis. Saxagliptin is known for its potent effect and long duration of action. In this study, we compared the efficacy of Saxagliptin with Mitiglinid for diabetes control and renal anemia in hemodialysis patients with type 2 diabetes mellitus. Methods: We performed a 6-month prospective, open-label, parallel group study of 41 patients with type 2 diabetes mellitus undergoing hemodialysis who took alpha-glucosidase inhibitors or meglitinides and did not use insulin. Saxagliptin and Mitiglinid were administered at 2.5 and 5 mg/day, respectively. The primary outcomes were changes in hemoglobin A1c (HbA1c) and glycated albumin (GA). Other efficacy assessments included changes in Hb, darbepoetin alpha (DA) dose, and erythropoietin responsiveness index (ERI). Results: No patient required an increase in Saxagliptin or Mitiglinid dose, and there were no cases of hypoglycemia with symptoms. HbA1c and GA values were not significantly different between both groups. For HbA1c, the gradient of the regression line of the Saxagliptin and Mitiglinid groups were Y =-7.144e-005∗X + 6.023 and Y =-0.02604∗X + 6.292, respectively, and no significant difference was found (p = 0.3281). However, for GA, the regression line of the Saxagliptin group significantly decreased (Y =-0.5036∗X + 19.34 and Y =-0.2346∗X + 18.79, p = 0.0371). Both groups did not have a significant change in the DA dose through the observation period. However, the DA dose of the Saxagliptin group significantly decreased when we compared the regression lines (Y =-0.8304∗X + 21.06 and Y = 0.6286∗X + 16.12, p = 0.0019) of both groups. Furthermore, ERI did not change significantly but showed a significant difference when regression lines were compared (Y =-0.2030∗X + 6.654 and Y = 0.1116∗X + 5.288, p = 0.0082). Conclusions: The present study showed that Saxagliptin was not inferior to Mitiglinid in the glycemic control of ESRD patients with type 2 diabetes mellitus, and it is well tolerated and safe. Saxagliptin may also improve bioavailability of iron compared to Mitiglinid, but long-Term follow-up in a large scale study with more precise ferrokinetic marker measurements are necessary to confirm these results.