ONWARDS 5: Weekly insulin therapy guided by app improves glycemic control

Key takeaways:

• Changes in HbA1c were greater with icodec used in conjunction with an app compared with once-daily basal insulin analogues.
• Patient compliance and satisfaction were also greater.

Patients with type 2 diabetes who used icodec titrated with the help of an app saw greater reductions in HbA1c compared with once-daily basal insulin analogues dosed per standard clinical practice, a randomized clinical trial showed.

The study, which researchers said incorporated “real-world elements,” also showed greater patient satisfaction and compliance with weekly icodec injections.

In those with type 2 diabetes, “missed insulin injections and inadequate dose titration of daily basal insulins can lead to suboptimal glycemic control,” Harpreet S. Bajaj, MD, MPH, the medical director of endocrine and metabolic research at LMC Healthcare in Canada, and colleagues wrote in Annals of Internal Medicine.

However, “a once-weekly dosing schedule could improve treatment adherence and persistence,” they suggested. “Technological advances (such as automated dosing guidance systems) may also improve treatment satisfaction and glycemic control for people living with [type 2 diabetes].”

Bajaj and colleagues conducted the phase 3a ONWARDS 5 trial to evaluate the long-term effectiveness in glycemic control, patient-reported outcomes and safety of icodec titrated with a dosing guide app vs. once-daily basal insulin analogues (OD analogues) dosed per standard clinical practice.

The trial included 1,085 insulin-naive adults with type 2 diabetes across 72 countries who were assigned to either icodec with the app or OD analogues in a 1:1 ratio.

Overall, the estimated mean change in HbA1c level from baseline to 52 weeks was greater with icodec with app vs. OD analogues (estimated treatment difference [ETD] = –0.38 percentage points; 95% CI, –0.66 to –0.09). Bajaj and colleagues said this translates to a difference in the estimated average glucose level of roughly 11 mg/dL — a number they called potentially clinically significant “especially given that insulin injection frequency was reduced to once per week with no compromise in safety.”

The researchers also found that at 52 weeks, patient-reported satisfaction and compliance were superior with icodec and the app compared with OD analogues, with ETDs of:

• 3.04 (95% CI, 1.28-4.81) for the Treatment-Related Impact Measure for Diabetes compliance domain score; and
• 0.78 (95% CI, 0.1-1.47) for the Diabetes Treatment Satisfaction Questionnaire total treatment satisfaction score.

“However, when interpreting the results from this trial, it should be noted that participants assigned to OD analogues received one intervention, whereas those randomly assigned to icodec with app had two interventions, and the design of ONWARDS 5 precludes differentiation between the effects of icodec and the dosing app,” they wrote.

Ultimately, however, this approach “could conceivably address several challenges seen in everyday practice, including inadequate dose titration and nonadherence to prescribed treatment regimens,” they concluded.