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

Abstract

AimsTo 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.MethodsThis 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 HbA1c (%) after 26 weeks.ResultsChange in HbA1c at Week 26 was IDegAspSimple −14.6 mmol/mol (−1.3%) (to 52.4 mmol/mol; 6.9%) and IDegAspStepwise −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 IDegAspSimple to IDegAspStepwise (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 IDegAspStepwise [2.1 per patient years of exposure (PYE)] vs. IDegAspSimple (3.3 PYE) (estimated rate ratio IDegAspSimple/IDegAspStepwise 1.8; 95% CI 1.1, 2.9). Nocturnal hypoglycaemia rates were similar between groups. No severe hypoglycaemic events were reported.ConclusionsIn participants with insulin‐naïve Type 2 diabetes mellitus, the IDegAspSimple titration algorithm improved HbA1c levels as effectively as a Stepwise titration algorithm. Hypoglycaemia rates were lower in the Stepwise arm.