Better glycaemic control and less hypoglycaemia with insulin glargine 300 U/mL vs glargine 100 U/mL: 1‐year patient‐level meta‐analysis of the EDITION clinical studies in people with type 2 diabetes

AIMS: To investigate the efficacy and safety of insulin glargine 300 U/mL (Gla‐300) vs insulin glargine 100 U/mL (Gla‐100) over 12 months in a patient‐level meta‐analysis, using data from the EDITION studies in people with type 2 diabetes (T2DM). METHODS: EDITION 1, 2 and 3 were multicentre, randomized, open‐label, 2‐arm, parallel‐group, treat‐to‐target phase IIIa studies. Similar study designs and endpoints enabled a meta‐analysis to be conducted. RESULTS: Reductions in glycated haemoglobin (HbA1c) were better sustained over 12 months with Gla‐300 than with Gla‐100 (least squares [LS] mean difference in change from baseline: −0.10 % [95% confidence interval {CI} −0.18 to −0.02] or −1.09 mmol/mol [95% CI −2.01 to −0.20]; P = .0174). Risk of confirmed (≤3.9 mmol/L) or severe hypoglycaemia was 15% lower with Gla‐300 vs Gla‐100 at night (relative risk 0.85 [95% CI 0.77–0.92]) and 6% lower at any time of day (relative risk 0.94 [95% CI 0.90–0.98]). Rates of hypoglycaemia were 18% lower with Gla‐300 vs Gla‐100 at night (rate ratio 0.82 [95% CI 0.67–0.99]), but comparable at any time of day. HbA1c <7.0 % without nocturnal hypoglycaemia was achieved by 24% more participants with Gla‐300 than with Gla‐100 (relative risk 1.24 [95% CI 1.03–1.50]). Severe hypoglycaemia was rare; in both treatment groups the incidence of events at any time of day was ≤3.6%, while rates were ≤0.08 events per participant‐year. CONCLUSIONS: In a broad population of people with T2DM over 12 months, use of Gla‐300 provided more sustained glycaemic control and significantly lower hypoglycaemia risk at night and at any time of day compared with Gla‐100.