New insulin glargine 300 U/mL: glycaemic control and hypoclycaemia in insulin-naïve people with type 2 diabetes mellitus (EDITION 3)

Background and aims: EDITION 3 studied the efficacy and safety of new insulin glargine 300 U/mL (U300) vs. glargine 100 U/mL (Gla-100) in people with type 2 diabetes mellitus uncontrolled on non-insulin therapy. Materials and Methods: 6-month, multicenter, open-label study; participants randomized to once-daily Gla-300 or Gla-100 in the evening while stopping sulfonylureas. Insulin was titrated seeking fasting SMPG 4.4 – 5.6 mmol/L (80 – 100 mg/dL). Primary endpoint was HbA1c change from baseline to month 6. Main secondary endpoint was percentage of participants with ≥1 confirmed (≤3.9 mmol/L (≤70 mg/dL)) or sev…