Analysis of patient characteristics and safety of insulin glargine U300 use in 21 359 patients with type-2 diabetes and chronic kidney disease: DPV registry study

Abstract

Aims: Managing type-2 diabetes (T2D) in chronic kidney disease (CKD) patients requires consideration of kidney function, and many drugs have not been investigated thoroughly. Clinical studies have demonstrated Glargine U300 (Gla-300) supports achievement of adequate glycemic control at low hypoglycemia risk. Materials and Method: This cross-sectional study analysed routine data of 21 359 T2D patients with CKD (1786 using Gla-300; 19 568 without any insulin) from the prospective Diabetes-Patienten-Verlaufsdokumentation (DPV) registry to evaluate patient characteristics and safety of Gla-300 use across different CKD stages. Results: Patients on Gla-300 had T2D onset at an earlier age (median age 55.1 vs. 62.3 years), longer diabetes duration (17.3 vs. 11.3 years), higher body weight (91.3 vs. 83.9 kg) and HbA1c levels (7.3% vs. 6.7%) than non-insulin patients (all p < 0.001). Gla-300 usage increased from CKD stage 1–4 (median dose 44 vs. 55 units) with higher baseline HbA1c levels (7.2% vs. 7.4%). Although severe hypoglycemia rates were low, a slight increase (0.01%/PY vs. 0.04%/PY) was observed with decreasing estimated glomerular filtration rate levels. Compared to others, stage 5 CKD patients had a distinct profile with lower HbA1c levels (6.9%), body weight (90 kg) and higher Gla-300 usage (50 units). Metformin, SGLT-2 inhibitors and GLP-1 RA were common concomitant drugs with diminished usage in advanced CKD stages, while Gla-300 was common at all stages. Conclusion: Despite variations in patient profiles, Gla-300 is widely used across all CKD stages, particularly in advanced stages with a low rate of severe hypoglycemia, suggesting its safe administration in CKD patients.