Insulin glargine 300 U/mL versus first‐generation basal insulin analogues in insulin‐naïve adults with type 2 diabetes: 12‐month outcomes of ACHIEVE Control, a prospective, randomized, pragmatic real‐life clinical trial

AIM: To report the effectiveness and safety of insulin glargine 300 U/mL (Gla‐300) versus standard‐of‐care basal insulin analogues (SOC‐BI) at 12 months in the ACHIEVE Control trial, which is a prospective pragmatic randomized real‐life study in insulin‐naïve adults with type 2 diabetes (T2D). METHODS: A total of 3304 insulin‐naïve adults with T2D and glycated haemoglobin (HbA1c) concentration of 64 to 97 mmol/mol (8.0% to 11.0%) after ≥1 year of treatment with two or more antihyperglycaemic agents were randomized to Gla‐300 or SOC‐BI. Key secondary endpoints included HbA1c target attainment without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia at 12 months. RESULTS: At 12 months, 26.1% (Gla‐300) and 23.7% (SOC‐BI) of adults achieved HbA1c targets without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia (odds ratio [OR] 1.14, 95% confidence interval [CI] 0.97–1.35); 33.0% and 29.5%, respectively, achieved HbA1c targets without documented symptomatic (<3.0 mmol/L [<54 mg/dL]) or severe hypoglycaemia (OR 1.19, 95% CI 1.02–1.38). The OR for HbA1c target achievement was 1.15 (95% CI 0.99–1.34), and favoured Gla‐300 versus SOC‐BI for absence of documented symptomatic or severe hypoglycaemia at 12 months for both ≤3.9 mmol/L (≤70 mg/dL; OR 1.21, 95% CI 1.05–1.40) and < 3.0 mmol/L (<54 mg/dL; OR 1.26, 95% CI 1.07–1.48). CONCLUSION: Gla‐300 tended to be associated with lower hypoglycaemia risk than SOC‐BI in real‐world clinical practice during the 12‐month follow‐up.