Efficacy and safety of switching to insulin glargine 300 U/mL in people with type 2 diabetes uncontrolled on basal insulin in China: A post hoc subpopulation analysis of the INITIATION study.

Abstract

Aims: To evaluate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) in people with uncontrolled type 2 diabetes (T2D) switching from another basal insulin (BI).

Materials and methods: INITIATION was an interventional, single-arm, phase IV study conducted in China. In this post hoc subpopulation analysis, the efficacy and safety of switching to Gla-300 was investigated in individuals with uncontrolled T2D (HbA1c 7.5%-11.0% [58-97 mmol/mol]) with previous BI. The primary endpoint was HbA1c change at week 24. Other measures of glycaemia, hypoglycaemia, insulin dose and weight change were assessed.

Results: Three hundred and two participants switched to Gla-300 from another BI, including 232 from insulin glargine 100 U/mL (Gla-100) and 55 from insulin degludec (IDeg). At week 24, the mean ± standard error (SE) HbA1c change from baseline was -0.87% ± 0.06% (-9.5 ± 0.7 mmol/mol; p <0.001). Significant reductions in fasting plasma glucose (least-squares mean [LSM] change -1.13 mmol/L) and fasting self-measured blood glucose (LSM change -1.36 mmol/L) were also observed (both p <0.001). The mean daily BI dose increased from 18.86 U (0.27 U/kg) at baseline to 28.83 U (0.41 U/kg) at week 24. During the 24-week treatment period, the incidence of any hypoglycaemia was 43.8% for all hypoglycaemia and 15.1% for nocturnal hypoglycaemia; the incidence of severe hypoglycaemia was low (0.7%). Minimal body weight change was documented.

Conclusions: Gla-300 improved glycaemic control with a relatively low hypoglycaemia risk and minimal weight gain in Chinese people with T2D uncontrolled on previous BI.