Glycaemic control and hypoglycaemia with new insulin glargine 300 U/mL in people with type 1 diabetes (EDITION 4)

Background and aims: EDITION 4 studied the efficacy and safety of new insulin glargine 300 U/mL (Gla-300) compared with glargine 100 U/mL (Gla-100) in people with T1DM. Materials and methods: In this 6-month, multinational, multicenter, open-label study, participants (N = 549, BMI 27.6 kg/m2, diabetes duration 21.0 years, HbA1c 8.1% [65 mmol/mol]) were randomized 1:1:1:1 to once-daily Gla-300 or Gla-100, morning or evening, while continuing mealtime insulin. Results: Gla-300 was non-inferior to Gla-100 for HbA1c change from baseline (primary endpoint) (LS mean change [SE] –0.40 [0.05] % (–4.4 [0.6] mmol/mol) and…