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, randomised, pragmatic real‐life clinical trial

AIMS ACHIEVE Control, a prospective pragmatic randomised real-life study in insulin-naive adults with type 2 diabetes (T2D), demonstrated statistical superiority of insulin glargine 300 U/mL (Gla-300) over first-generation standard-of-care basal insulin analogues (SOC-BI; insulin glargine 100 U/mL or insulin detemir) for the primary composite endpoint of individualised HbA1c target achievement without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia at 6 months. Here, we report effectiveness and safety of Gla-300 versus SOC-BI in ACHIEVE Control at 12 months. METHODS 3304 insulin-naive adults with T2D and HbA1c 8%-11% after ≥1 year of treatment with ≥2 antihyperglycaemic agents were randomised to Gla-300 or SOC-BI. Key secondary endpoints included HbA1c target attainment without documented symptomatic or severe hypoglycaemia (≤3.9 mmol/L [≤70 mg/dL]) 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% 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). Odds ratio 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 hypoglycemia risk than SOC-BI in real-world clinical practice during the 12-month follow-up. This article is protected by copyright. All rights reserved.