Background and Aims

Insulin glargine 300U/ml (Gla-300) is a second-generation basal insulin analogue that is associated with lower risk of hypoglycaemia and glycaemic variability (GV). We compared GV and time-in-range (TIR) in Chinese T2D patients initiated on once daily bedtime Gla-300 versus NPH.

Methods

This was a 24-week, 1:1 randomized, open-label study, comparing patient-adjusted titration of Gla-300 versus NPH at bedtime in 50 insulin-naïve T2D patients on maximal oral antidiabetic drugs. The starting dose was 0.2U/kg/day and with self-titration of 1 unit per week to achieve a target fasting glucose of 4.4 to 6 mmol/l, without hypoglycaemia. Patients had seven-day professional continuous glucose monitoring (CGM) (Medtronic iPro®2 with Enlite sensor) at baseline, week 12 and 24. The nocturnal period was defined as 00:00 to 06:00 hours.

Results

Percentage TIR between 3.9 to 10mmol/l was similar in NPH and Gla-300 groups at baseline (Mean ±SD 48±16 versus 47±22 %). At 24 weeks, overall TIR was similar between NPH and Gla-300 groups (61±16 versus 60±17%) with no difference in GV. During the nocturnal period, % time below 3.9mmol/l was significantly lower in the Gla-300 group (p =0.04, Fig 1). Nocturnal GV as expressed by the coefficient of variation was significantly lower in Gla-300 verus NPH groups (25±6% versus 34±9% , p = 0.008). There were no differences between groups in TIR or GV during daytime hours.

Conclusions

Once daily bedtime Gla-300 was associated with lower nocturnal GV and CGM-detected hypoglycaemia as compared with NPH insulin.

Funding: Sanofi investigator-initiated study