Insulin degludec/insulin aspart once daily in Type 2 diabetes: a comparison of simple or stepwise titration algorithms (BOOST (®): SIMPLE USE)

AIMS: To compare the efficacy and safety of two titration algorithms for insulin degludec/insulin aspart (IDegAsp) administered once daily with metformin in participants with insulin‐naïve Type 2 diabetes mellitus. METHODS: This open‐label, parallel‐group, 26‐week, multicentre, treat‐to‐target trial, randomly allocated participants (1:1) to two titration arms. The Simple algorithm titrated IDegAsp twice weekly based on a single pre‐breakfast self‐monitored plasma glucose (SMPG) measurement. The Stepwise algorithm titrated IDegAsp once weekly based on the lowest of three consecutive pre‐breakfast SMPG measurements. In both groups, IDegAsp once daily was titrated to pre‐breakfast plasma glucose values of 4.0–5.0 mmol/l. Primary endpoint was change from baseline in HbA(1c) (%) after 26 weeks. RESULTS: Change in HbA(1c) at Week 26 was IDegAsp(Simple) −14.6 mmol/mol (−1.3%) (to 52.4 mmol/mol; 6.9%) and IDegAsp(Stepwise) −11.9 mmol/mol (−1.1%) (to 54.7 mmol/mol; 7.2%). The estimated between‐group treatment difference was −1.97 mmol/mol [95% confidence interval (CI) −4.1, 0.2] (−0.2%, 95% CI −0.4, 0.02), confirming the non‐inferiority of IDegAsp(Simple) to IDegAsp(Stepwise) (non‐inferiority limit of ≤ 0.4%). Mean reduction in fasting plasma glucose and 8‐point SMPG profiles were similar between groups. Rates of confirmed hypoglycaemia were lower for IDegAsp(Stepwise) [2.1 per patient years of exposure (PYE)] vs. IDegAsp(Simple) (3.3 PYE) (estimated rate ratio IDegAsp(Simple)/IDegAsp(Stepwise) 1.8; 95% CI 1.1, 2.9). Nocturnal hypoglycaemia rates were similar between groups. No severe hypoglycaemic events were reported. CONCLUSIONS: In participants with insulin‐naïve Type 2 diabetes mellitus, the IDegAsp(Simple) titration algorithm improved HbA(1c) levels as effectively as a Stepwise titration algorithm. Hypoglycaemia rates were lower in the Stepwise arm.