Insulin degludec/insulin aspart once daily in Type 2 diabetes: a comparison of simple or stepwise titration algorithms (BOOST super( registered ): 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-naive Type 2 diabetes mellitus. Methods This open-label, parallel-group, 26-week, multicentre, treat-to-target trial,...

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Published in:Diabetic medicine 2017-02, Vol.34 (2), p.174-179
Main Authors: Park, S W, Bebakar, WMW, Hernandez, P G, Macura, S, Hersloev, M L, Rosa, R
Format: Article
Language:English
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Summary: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-naive 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 sub(1c) (%) after 26 weeks. Results Change in HbA sub(1c) at Week 26 was IDegAsp sub(Simple) -14.6 mmol/mol (-1.3%) (to 52.4 mmol/mol; 6.9%) and IDegAsp sub(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 sub(Simple) to IDegAsp sub(Stepwise) (non-inferiority limit of less than or equal to 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 sub(Stepwise) [2.1 per patient years of exposure (PYE)] vs. IDegAsp sub(Simple) (3.3 PYE) (estimated rate ratio IDegAsp sub(Simple)/IDegAsp sub(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-naive Type 2 diabetes mellitus, the IDegAsp sub(Simple) titration algorithm improved HbA sub(1c) levels as effectively as a Stepwise titration algorithm. Hypoglycaemia rates were lower in the Stepwise arm. What's new? * The co-formulation, insulin degludec/insulin aspart (IDegAsp), provides basal and mealtime insulin coverage in a single injection. * IDegAsp may be titrated using two titration algorithms, Simple (titrated twice weekly) or Stepwise (titrated once weekly). Both algorithms effectively reduce HbA sub(1c) levels in participants with insulin-naive Type 2 diabetes, with similar rates of nocturnal hypoglycaemia and no reported severe hypoglycaemic events. IDegAsp sub(Stepwise) leads to significantly lower rates of overall confirmed hypoglycaemi
ISSN:0742-3071
1464-5491
DOI:10.1111/dme.13069