Once-weekly insulin icodec showed a safety profile broadly similar to once-daily basal insulin comparators in adults with diabetes, according to a pooled analysis of the ONWARDS phase 3a trials published in Endocrine Practice.
The analysis pooled adverse event data from six phase 3a randomized trials (ONWARDS 1-6) involving 4,340 adults with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM). Participants received either once-weekly insulin icodec or once-daily basal insulin comparators. Total treatment exposure was 2118.70 patient-years of exposure (PYE) with icodec and 2127.76 PYE with comparator insulins.
Findings
- Adjusted rates of all adverse events were similar between icodec and comparator groups (248.49 vs 242.53 events/100 PYE).
- Serious adverse event rates were also similar (14.51 vs 14.03 events/100 PYE), as were severe adverse event rates (7.92 vs 7.50 events/100 PYE).
- Hypersensitivity rates were comparable between groups (5.88 vs 6.74 events/100 PYE).
- Injection-site reactions occurred more frequently with icodec (5.86 vs 3.66 events/100 PYE), although most events were mild.
- Medication error rates were similar between groups (2.47 vs 2.53 events/100 PYE).
- Time to first major adverse cardiovascular event was comparable between groups (hazard ratio [HR] 0.93; 95% confidence interval [CI], 0.56-1.56).
Once-weekly insulin icodec showed safety outcomes comparable to once-daily basal insulin in adults with T1DM or T2DM across the ONWARDS trials. Injection-site reactions occurred more frequently with icodec, although most events were mild. No major differences were observed in medication errors or cardiovascular events between treatment groups.
