Efficacy and safety of insulin glargine 300 U/mL versus insulin glargine 100 U/mL in Asia Pacific insulin-naïve people with type 2 diabetes: The EDITION AP randomized controlled trial

Abstract

Aim: To compare the efficacy and safety of Gla-300 versus Gla-100 in insulin-naïve people with type 2 diabetes in Asia Pacific.

Materials and methods: In this open-label, randomized, active-controlled, 26-week study, insulin-naïve participants with type 2 diabetes inadequately controlled with non-insulin antihyperglycaemic drugs were randomized (2:1) to Gla-300 or Gla-100. The initial daily dose of basal insulin was 0.2 U/kg and was adjusted at least weekly for 8-12 weeks to a target fasting self-monitored plasma glucose (SMPG) of 4.4-5.6 mmol/L.

Results: Of the 604 participants randomized, 570 (Gla-300, n = 375; Gla-100, n = 195) completed the study. Non-inferiority of Gla-300 versus Gla-100 in HbA1c reduction from baseline to week 26 was confirmed. In the Gla-300 and Gla-100 groups, 51.1% and 52.2% of participants achieved the HbA1c target of <7.0% (rate ratio [95% CI]: 0.98 [0.84 to 1.14]) and 19.1% and 21.9% achieved the target without hypoglycaemia during the last 12 weeks of treatment (rate ratio [95% CI]: 0.87 [0.63 to 1.20]). Changes in fasting plasma glucose and 24-hour average eight-point SMPG were comparable between groups. Incidence of hypoglycaemia at any time of day was similar between treatment groups at week 26, but incidence of any nocturnal hypoglycaemia was numerically lower with Gla-300 than Gla-100 over the initial 12-week titration period and 26-week on-treatment period. Rates of adverse events were similar between groups and low for serious adverse events.

Conclusions: Glycaemic control of Gla-300 is non-inferior to Gla-100 with a similar or lower incidence and proportion of hypoglycaemia in people with type 2 diabetes in Asia Pacific, reinforcing the results in the global EDITION programme.

Keywords: basal insulin; glycaemic control; hypoglycaemia; insulin analogues; insulin therapy; population study.

Figure 1

Mean change in (A) HbA1c and (B) eight‐point self‐monitored plasma glucose (SMPG) profiles. SE, standard error

Figure 2

(A) Incidence and (B) event rate per participant‐year of hypoglycaemia at any time of day (24 hours). CI, confidence interval; RR, rate ratio

Figure 3

(A) Incidence and (B) event rate per participant‐year of nocturnal hypoglycaemia (00:00 to 05:59). CI, confidence interval; NE, not evaluable; RR, rate ratio