Icodec with app superior to OD analogues in insulin-naive T2D

Once-weekly insulin icodec with a dosing guide app is better than once-daily (OD) basal insulin analogues at reducing glycated haemoglobin (HbA1c) and improving treatment satisfaction and compliance in patients with type 2 diabetes (T2D), a study has shown. In addition, hypoglycaemia rates were low and similar between treatment groups.

This randomized, open-label, parallel-group, phase IIIa trial was conducted for 52 weeks in 176 sites across seven countries. The investigators randomly assigned 1,085 insulin-naïve adults with T2D to either once-weekly icodec with a dosing guide app or OD analogue (ie, insulin degludec, insulin glargine U100, or insulin glargine U300).

Change in HbA1c level from baseline to week 52 was the primary outcome, while patient-reported outcomes (Treatment Related Impact Measure for Diabetes [TRIM-d] compliance domain score and change in Diabetes Treatment Satisfaction Questionnaire [DTSQ] total treatment satisfaction score) were secondary.

At 52 weeks, patients on icodec with app showed greater estimated mean change in HbA1c level from baseline than those on OD analogues. Noninferiority (p<0.001) and superiority (p=0.009) of the icodec with app was confirmed in prespecified hierarchical testing (estimated treatment difference [ETD], ‒0.38 percentage points, 95 percent confidence interval [CI], ‒0.66 to ‒0.09).

Patient-reported outcomes at week 52 were also more favourable with icodec with app than with OD analogues (TRIM-D: ETD, 3.04, 95 percent CI, 1.28‒4.81; DTSQ: ETD, 0.78, 95 percent CI, 0.10‒1.47). Additionally, the rates of clinically significant or severe hypoglycaemia were low and similar between the two groups.

This study was limited by its inability to differentiate the effects of icodec and the dosing guide app, according to the investigators.