medwireNews: Weekly insulin icodec, guided by a dosing app, offers greater reductions in glycated hemoglobin (HbA1c) than once-daily basal insulin analogs in people with type 2 diabetes, show findings from the ONWARDS 5 trial.
Writing in the Annals of Internal Medicine, Harpreet Bajaj (LMC Diabetes and Endocrinology, Brampton, Ontario, Canada) and co-authors say that this regimen “could conceivably address several challenges seen in everyday practice, including inadequate dose titration and nonadherence to prescribed treatment regimens.”
The 52-week phase 3a study was conducted at 176 sites across seven countries, and had broad inclusion criteria, with the 1085 participants with type 2 diabetes selected “on the basis of generalizability to clinical practice,” the researchers note.
They report: “For example, 33% of participants were aged 65 years or older, and 68% had an HbA1c level above 8% at baseline.”
Among the 542 people randomly assigned to receive insulin icodec plus the app, the estimated mean HbA1c level decreased from 8.96% at the start of the study to 7.24% at week 52. This compared with a mean decrease from 8.88% to 7.61% among the 543 people randomly assigned to receive insulin analogs (insulin degludec, insulin glargine U100, or glargine U300) for 52 weeks dosed according to standard practice.
This resulted in estimated mean reductions of 1.68 and 1.31 percentage points, respectively, and a significant 0.38 percentage point treatment difference in favor of insulin icodec plus the app.
This “translates to a difference in estimated average glucose level of approximately 11 mg/dL (0.61 mmol/L),” and confirms noninferiority and superiority of insulin icodec plus app versus insulin analogs, the team writes.
Patient-reported outcomes also improved more with insulin icodec than insulin analogs, with average scores on Treatment Related Impact Measure for Diabetes at 52 weeks of 90.42 versus 87.37, respectively, and 31.13 versus 30.35 on the Diabetes Treatment Satisfaction Questionnaire.
Also, both treatments had low and similar rates of clinically significant or severe hypoglycemia, at a combined 0.19 versus 0.14 events per person–years of exposure for insulin icodec and insulin analogs, respectively.
“When interpreting the results from this trial, it should be noted that participants assigned to [once-daily] analogues received 1 intervention, whereas those randomly assigned to icodec with app had 2 interventions (icodec and the dosing guide app), and the design of ONWARDS 5 precludes differentiation between the effects of icodec and the dosing app,” say the researchers.
They continue: “These results indicate that a supporting titration app could address the lack of titration often seen with insulin in clinical practice.”
Bajaj et al conclude: “The higher level of compliance in this trial and the higher weekly insulin dose achieved with icodec with app versus [once-daily] analogues may help to overcome inadequate dose titration and poor treatment adherence, which could in turn help to achieve better glycemic control in clinical practice.”
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