Weekly insulin icodec superior to daily insulin analogues in latest manufacturer trial
Patients with type 2 diabetes who used weekly insulin icodec and a dosing app had greater reductions in HbA1c levels than similar patients randomized to start a daily insulin analogue with a traditional dosing strategy.
Patients using weekly insulin icodec with an app to guide their dosing had greater reductions in HbA1c levels than those who took daily basal insulin analogues, an industry-funded trial found.
The phase 3a trial, called ONWARDS 5, randomized 1,085 insulin-naive adults with type 2 diabetes in seven countries to either weekly insulin icodec dosed by an app or a daily insulin analogue (insulin degludec, insulin glargine U100, or insulin glargine U300) dosed in a standard manner. The primary outcome was change in HbA1c level from baseline to week 52. The study was funded by Novo Nordisk and published by Annals of Internal Medicine on Sept. 26.
At week 52, the estimated mean change in HbA1c level was greater with the weekly insulin than the daily analogues (estimated treatment difference, 0.38 percentage point; 95% CI, 0.66 to 0.09 percentage point), showing the weekly insulin to be both noninferior (P<0.001) and superior (P=0.009). Patient-reported outcomes on adherence and satisfaction also favored the weekly insulin, and rates of clinically significant or severe hypoglycemia were low and similar with both treatments.
“This is the first trial using several real-world elements to improve generalizability in an evaluation of the long-term effectiveness and safety” of weekly versus daily insulin, the study authors said, noting that a third of participants were ages 65 years or older and two-thirds had an HbA1c level above 8% at baseline.
Limitations of the study include that it couldn't differentiate between the effects of weekly insulin and those of the dosing app, but comparing the reductions in HbA1c levels in this trial with those in trials of only the insulin, not the app, suggest that the app had a beneficial effect, the authors said. “Once-weekly icodec with a dosing guide app could conceivably address several challenges seen in everyday practice, including inadequate dose titration and nonadherence to prescribed treatment regimens,” they concluded.