medwireNews: Once-weekly insulin icodec is noninferior to once-daily insulin degludec in people with type 1 diabetes, indicate findings from the ONWARDS 6 trial, with a low, albeit higher, risk for hypoglycemia.
The study involved 582 adults (57% men) aged a mean of 44.2 years who had a mean type 1 diabetes duration of 19.5 years and were receiving basal bolus insulin. They were randomly assigned to receive once-weekly insulin icodec or once-daily degludec in addition to aspart insulin for a main phase of 26 weeks, followed by a further 26-week extension phase.
After 26 weeks of treatment, glycated hemoglobin (HbA1c) levels decreased by a mean 0.47 percentage points among 290 people with type 1 diabetes taking once-weekly insulin icodec, from 7.59% (59.50 mmol/mol) at baseline to 7.15% (54.60 mmol/mol). This did not significantly differ from the 0.51 percentage point decrease among 292 people taking once-daily insulin degludec, from 7.63% to 7.10% (59.90 to 54.10 mmol/mol).
“Non-inferiority of icodec to degludec” was therefore confirmed, presenter David Russell-Jones, from the University of Surrey in Guildford, UK, told delegates at the 59th EASD Annual Meeting in Hamburg, Germany.
However, he noted that by week 52 there was a significant 0.17 percentage point difference in the mean change in HbA1c between the two treatments in favor of degludec.
The mean reduction from baseline was 0.37 percentage points to 7.24% (55.60 mmol/mol) for the icodec group and 0.54 percentage points to 7.07% (53.8 mmol/mol) for degludec.
The risk for clinically significant or severe hypoglycemia at 26 weeks was increased by a significant 89% among people taking insulin icodec compared with degludec and by a significant 80% at week 52. The overall number of events at week 26 was 19.93 versus 10.37 per person–year of exposure in the icodec and degludec arms, respectively, and 17.00 versus 9.16 per person–year at week 52.
Putting this increased risk into perspective, Russell-Jones highlighted that the overall event rates were “incredibly low,” when compared with “in the region of 40–80 events” seen in the degludec development program.
He also reported that there was no difference between the two treatment in terms of time spent in range (3.9–10.0 mmol/l; 70–180 mg/dL) and time spent above range, but a significantly greater percentage of time was spent below 3.0 mmol/L (54 mg/dL) with icodec during the first 26 weeks only, at 1.0% versus 0.7% with degludec.
Regarding safety, the incidence of adverse events was similar across the two treatment groups, at 82.8% and 80.8% with insulin icodec and degludec, respectively, and “no new safety issues were identified,” he confirmed.
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