ONWARDS 1: Benefits of once-weekly vs. daily insulin sustained through 83 weeks
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Key takeaways:
- Adults with type 2 diabetes saw improved HbA1c and time in the recommended glucose range with once-weekly vs. daily insulin therapy.
- Weekly insulin may reduce insulin burden and improve treatment adherence.
SAN DIEGO — Adults with type 2 diabetes naive to insulin therapy saw a long-term reduction in HbA1c and superior time in the recommended glucose range with once-weekly insulin icodec compared with daily insulin glargine, data show.
ONWARDS 1, the longest trial in the ONWARDS development program for insulin icodec (Novo Nordisk), showed that the novel weekly insulin regimen facilitated the initiation of basal insulin treatment improved glycemic control and potentially treatment adherence through reducing the insulin injection burden for people with type 2 diabetes who had not previously received insulin, Julio Rosenstock, MD, FACE, director of the Dallas Diabetes Research Center at Medical City Dallas and clinical professor of medicine at the University of Texas Southwestern Medical Center, said during a presentation.
The findings were simultaneously published in The New England Journal of Medicine.
“This reduction in the glycated hemoglobin level with icodec was maintained to week 78,” Rosenstock and colleagues wrote. “A slight further reduction in the glycated hemoglobin level with glargine U100 led to the nonsignificance of the between-group difference at week 78. However, participants receiving icodec spent significantly more time in the target glycemic range than those receiving glargine U100 in weeks 48 to 52 (additional 1 hour and 1 minute per day) and weeks 74 to 78 (additional 1 hour and 4 minutes per day).”
In an open-label, treat-to-target phase 3 trial, Rosenstock and colleagues analyzed data from 984 adults with type 2 diabetes and an HbA1c ranging from 7% to 11% who had not previously received insulin therapy. The study was conducted at 143 sites across 12 countries, with an overall duration of 83 weeks. Researchers randomly assigned participants to once-weekly insulin icodec 700 UmL (n = 492; mean age, 59 years; 60% men) or once-daily insulin glargine U 100 (Lantus, Sanofi; n = 492; mean age, 59 years; 53.5% men). The primary endpoint was change in HbA1c from baseline to week 52; secondary endpoints included the percentage of time spent in the glycemic range of 70 to 180 mg/dL during weeks 48 to 52. Researchers also recorded any episodes of hypoglycemia.
At 52 weeks, mean HbA1c fell from 8.5% to 6.93% for participants assigned insulin icodec (mean change, –1.55 percentage points) and from 8.44% to 7.12% for those assigned insulin glargine (mean change, –1.35 percentage points). The estimated between-group difference of –0.19 percentage points (95% CI, –0.36 to –0.03) confirmed noninferiority (P < .001) and superiority (P = .02) of insulin icodec, Rosenstock said.
The percentage of time spent in the glycemic range of 70 to 180 mg/dL was higher with icodec vs. glargine U100 (71.9% vs. 66.9%; estimated between-group difference, 4.27 percentage points; 95% CI, 1.92-6.62; P < .001), which confirmed superiority.
Researchers did observe a higher incidence of combined clinically significant or severe hypoglycemia among those assigned insulin icodec vs. glargine U100, with rates of 0.3 vs. 0.16 events per person-year of exposure, respectively, at week 52 (estimated rate ratio, 1.64; 95% CI, 0.98-2.75) and 0.3 and 0.16 events per person-year of exposure, respectively, at week 83 (estimated rate ratio, 1.63; 95% CI, 1.02-2.61).
“Among persons with long-standing diabetes taking noninsulin glucose-lowering agents including GLP-1 receptor agonists and SGLT2 inhibitors, those who received icodec were more likely to reach a level below 7% than those who received glargine U100, and they spent more time in the target glycemic range and were more likely to reach a level below 7% without clinically significant or severe hypoglycemia,” the researchers wrote. “In this phase 3a trial, we found that once-weekly insulin icodec offered better glycemic control than once-daily insulin glargine U100 in persons with type 2 diabetes who had not previously received insulin.”
Reference:
Editor’s note: This article was updated on June 26, 2023, to accurately reflect the follow-up duration and the mean values in HbA1c reduction.
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Rosenstock J, et al. 179-OR. Presented at: American Diabetes Association Scientific Sessions; June 23-26, 2023; San Diego.
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