We are getting closer to the possibility of people with type 1 diabetes (T1D) needing to administer basal insulin only once a week instead of every single day, with Novo Nordisk announcing the latest results of its ONWARDS 6 clinical trial.
What was the clinical trial studying?
ONWARDS clinical trials, which have been ongoing for the past few years, have been separated into six trials. The first five trials were in people with type 2 diabetes – comparing the once-weekly insulin (called icodec) with a daily insulin, either insulin glargine (a long-acting modified form of medical insulin) or degludec (an ultralong-acting basal insulin analogue).
The latest trial, ONWARDS 6, compared the once-weekly insulin icodec to daily insulin degludec in people with T1D.
The results of ONWARDS 6 were presented at the European Association for the Study of Diabetes (EASD) conference, and simultaneously published in The Lancet. ONWARDS 6 was a large-scale study of 582 adults with T1D comparing the basal insulins (weekly icodec vs daily degludec) in combination with fast-acting insulin aspart.
The study was primarily looking to determine if there was a difference in HbA1c (a blood glucose measurement), as well as time-in-range, diabetes treatment satisfaction, and number of severe hypoglycemic episodes.
The researchers found no difference in HbA1c or time-in-rangebetween the people who took icodec vs those who took degludec. The weekly icodec group did have more episodes of hypoglycemia compared to the daily degludec group, however, the numbers of these episodes were quite low overall (20 and 10 events per patient year for the icodec and degludec groups, respectively).
Moreover, both groups had improved scores on the Diabetes Treatment Satisfaction Questionnaire, somewhat favouring the degludec group. While we may have expected treatment satisfaction to be higher in the weekly icodec group, the increased scores are likely attributable to receiving additional treatment and medical attention as part of the trial, as well as the fact that both groups improved their HbA1c scores by an average of 0.5%.
What do the trial results mean for people with T1D?
While weekly insulin icodec was as effective as daily insulin degludec at reducing HbA1c in people with T1D, it did lead to a higher rate of hypoglycemic episodes – although the overall rate of hypoglycemia was very low for both groups.
These results provide important information about the safety and effectiveness of weekly insulin and will inform the next round of icodec clinical trials. JDRF Canada will continue to monitor the progress and provide updates when available.