N Engl J Med
EASD: Once-weekly insulin efsitora effective in T2DM
In insulin-naïve adults with T2DM, once-weekly efsitora was noninferior to once-daily degludec in reducing glycated hemoglobin levels.
- In the phase 3 QWINT-2 trial, insulin-naïve adults with T2DM were randomly assigned in a 1:1 ratio to receive efsitora or degludec. Primary end point was change in the glycated hemoglobin level from baseline to week 52. Secondary and safety end points included change in glycated hemoglobin level in subgroups of participants using and not using GLP-1 receptor agonists, the percentage of time that the glucose level was in the target range of 70-180 mg/dL in weeks 48-52, and hypoglycemic episodes.
- A total of 928 participants underwent randomization (466 in the efsitora group and 462 in the degludec group). Mean glycated hemoglobin level decreased from 8.21% at baseline to 6.97% at week 52 with efsitora and from 8.24% to 7.05% with degludec (estimated treatment difference, -0.09 percentage points), demonstrating noninferiority.
- Time in range was slightly higher with efsitora vs. degludec (64.3% vs. 61.2%). The rate of combined clinically significant or severe hypoglycemia (per participant-year of exposure) was 0.58 with efsitora vs. 0.45 with degludec (estimated rate ratio, 1.30). No severe hypoglycemia events were reported with efsitora; six episodes were reported with degludec. Incidence of adverse events was similar between groups.
Source:
Wysham C, et al; QWINT-2 Investigators. (2024, September 10). N Engl J Med. Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment. https://pubmed.ncbi.nlm.nih.gov/39254740/