Dallas—Patients with T2D are often hesitant to adopt daily basal insulin and sometimes struggle with adherence when they do. That is why a new study demonstrating the efficacy of once-weekly insulin icodec treatment in people with insulin-naïve T2D is so important.

The study, published in the Journal of the American Medical Association to coincide with release at the American Diabetes Association’s 83rd Scientific Sessions in late June, demonstrated the efficacy of once-weekly insulin icodec treatment in patients with insulin-naïve T2D.

The randomized, double-masked, double-dummy trial, which enrolled 588 people with T2D, estimated mean glycosylated hemoglobin A1C (HbA1c) change from baseline to Week 26 was noninferior with insulin icodec (–1.6 percentage points) compared with insulin degludec (–1.4 percentage points), with confirmed statistical superiority (estimated treatment difference, –0.2 percentage points).

“Once-weekly insulin icodec could provide a simpler dosing alternative to daily basal insulin in people with type 2 diabetes,” wrote the authors of the University of Texas Southwestern Medical Center–led international study.

The study team sought to evaluate the efficacy and safety of once-weekly icodec versus once-daily insulin degludec, conducting the trial from March 2021 to June 2022 at 92 sites in 11 countries. The participants were adults with T2D treated with any noninsulin glucose–lowering agents with HbA1c of 7% to 11% (53-97 mmol/mol).

Those patients were randomly assigned in a 1:1 ratio to receive either once-weekly icodec and once-daily placebo or once-daily degludec and once-weekly placebo. The primary endpoint was defined as a change in HbA1c from baseline to Week 26 (noninferiority margin, 0.3% percentage points), with secondary endpoints including change in fasting plasma glucose from baseline to Week 26, mean weekly insulin dose during the last 2 weeks of treatment, body weight change from baseline to Week 26, and number of level 2 (clinically significant; glucose level <.001) hypoglycemic events and superiority (P = .002).

“There were no significant differences between the icodec and degludec groups for fasting plasma glucose change from baseline to week 26 (ETD [estimated treatment difference], 0 [95% CI, –6 to 5] mg/dL; P = .90), mean weekly insulin dose during the last 2 weeks of treatment, or body weight change from baseline to week 26 (2.8 kg vs. 2.3 kg; ETD, 0.46 [95% CI, –0.19 to 1.10] kg; P = .17),” the authors pointed out. “Combined level 2 or 3 hypoglycemia rates were numerically higher in the icodec group than the degludec group from Week 0 to 31 (0.31 vs. 0.15 events per patient-year exposure; P = .11) and statistically higher in the icodec group from Week 0 to 26 (0.35 vs. 0.12 events per patient-year exposure; P = .01).”

The researchers concluded that in insulin-naïve T2D patients, once-weekly icodec demonstrated superior HbA1c reduction to once-daily degludec after 26 weeks of treatment, with no difference in weight change. They advised that the higher rate of combined level 2 or 3 hypoglycemic events was in the context of less than one event per patient-year exposure in both groups.

“As type 2 diabetes progresses, insulin therapy may help to optimize glycemic control,” according to background information in the study. “Basal insulin initiation is recommended when noninsulin glucose–lowering agents are insufficient for glycemic control.”

The researchers emphasized that insulin icodec is a once-weekly basal insulin that “may improve treatment acceptance and adherence by reducing the number of basal insulin injections from at least 365 per year to 52 per year.”

Based on clinical trials, icodec is known to have a long half-life of approximately 1 week, with phase II trials in people with T2D demonstrating similar glycemic efficacy and safety profiles for icodec and once-daily insulin glargine. This study reports the results of the ONWARDS 3 trial, which assessed the efficacy and safety of once-weekly icodec versus once daily degludec in people with insulin-naïve type 2 diabetes.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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