Prospektywna ocena skuteczności i bezpieczeństwa insuliny glargine 100 U / ml (Gla-100) u dorosłych chorych na cukrzycę w Polsce: badanie obserwacyjne LARE

Abstract

Introduction. Insulin glargine 100 U/ml (Gla-100) is a long-lasting basal insulin analog injected once daily. This real-life study aimed to evaluate the efficacy and safety of Gla-100 in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM), who were recently switched from isophane (NPH) insulin. Methods. This multicenter, prospective, 52-week observational study included 321 patients with T1DM and 766 with T2DM. The primary endpoint was the percentage of participants with a HbA 1c reduction of ≥ 0.5% at 52 weeks. The secondary endpoints included fasting plasma glucose (FPG) and HbA1c reduction over time, and hypoglycemic events. Results. Of the 1,087 patients included, 69.9% achieved the primary endpoint, while the mean HbA 1c decreased by 1.03% and the mean FPG by 31.8 mg/dL at 52 weeks. The average annual rate of severe hypoglycemia was 0.017 events per patient-year and 0.82 events per patient-year for nocturnal hypoglycemia. The proportion of participants experiencing severe diurnal or nocturnal hypoglycemia was significantly lower in the four weeks prior to the study end than the four weeks before the switch from NPH insulin (p < 0.0001 for diurnal hypoglycemia in T1DM and < 0.002 for diurnal hypoglycemia in T2DM; p < 0.0001 for nocturnal hy-poglycemia in both T1DM and T2DM). Body weight did not change substantially throughout the study (mean increase of 0.3 kg for T1DM and 0.1 kg for T2DM). Conclusions. Patients with T1DM or T2DM in whom diabetes was not well controlled with NPH insulin treat-ment achieved better glycemic control at a lower risk of hypoglycemia after switching to Gla-100 in routine clinical practice.