The Step‑by‑Step trial (NCT02906917) compared the efficacy of insulin degludec/insulin aspart (IDegAsp) OD/BID with insulin glargine 100 units/mL (IGlar U100) OD plus insulin aspart (IAsp) OD/BID/TID over a 38-week treatment period, in patients with type 2 diabetes (T2D) (Figure 1). This post hoc analysis used patient-level modelling to assess predicted risk of hypoglycaemia with IDegAsp OD/BID versus IGlar U100 OD plus IAsp OD/BID/TID across a range of glycaemic values.
For each patient at each visit where HbA1c was recorded, normalised HbA1c values were linked with predicted risk of severe (ADA classification) or BG‑confirmed (<3.1 mmol/L) symptomatic hypoglycaemia since last visit. From this modelled association, estimated differences in glycaemic control with IDegAsp versus IGlar U100 plus IAsp at Weeks 26 and 38 were calculated using hypoglycaemia rate ratios from the trial.
For the same HbA1c reduction (e.g. 7.0% to 6.0%), the increase in predicted hypoglycaemia rate with IDegAsp was smaller (0.75 to 0.90; 20% increase) versus IGlar U100 plus IAsp (1.46 to 2.12; 45% increase; Figure 2). Estimated differences in glycaemic control with IDegAsp versus IGlar U100 plus IAsp at the same hypoglycaemia rates at Weeks 26 and 38 were −0.21% and −0.30%, respectively.
This analysis demonstrates a reduced risk of hypoglycaemia with IDegAsp versus IGlar U100 plus IAsp across a range of glycaemic values, in patients with T2D. The modelled association shows that at the same hypoglycaemia rate, IDegAsp is expected to result in a greater reduction in HbA1c versus IGlar U100 plus IAsp.