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.

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.