Introduction and Objective: Medication errors in basal insulin therapy can compromise patient safety and glycemic outcomes. In the QWINT 1-4 T2D trials, efsitora, a once-weekly innovative basal insulin, demonstrated non-inferior glycemic control and a safety profile comparable to daily basal insulins glargine and degludec (daily comparators). This study aimed to assess the prevalence of medication errors of interest (MEIs)—defined as multiple weekly doses or a repeated one-time starting dose for efsitora, or duplicate daily comparator doses—and clinical outcomes in participants with MEIs. Methods: Insulin-naïve (QWINT 1-2) or insulin-experienced (QWINT 3-4) participants (N=3439) received efsitora or daily comparators for 26, 52, or 78 weeks. Medication errors were recorded as adverse events, and descriptive statistics were reported. Results: Among efsitora-treated participants, 1.3% (24/1883) experienced 25 MEIs and 0.2% (3/1556) of the daily comparator participants experienced 4 MEIs. Investigator errors accounted for 60% of efsitora MEIs and 50% of daily comparator MEIs. Of the 24 participants with efsitora MEIs, 1 experienced level 2 hypoglycemia at the time of the MEI. Within 4 weeks post-MEI, 4 participants experienced level 2 and 1 participant also experienced level 3 hypoglycemia. No level 2 or 3 hypoglycemia events were reported for daily comparator MEIs. Mean HbA1c after MEI was 7.5% in both groups. Treatment period completion for participants with MEIs was 83.3% with efsitora and 100% with daily comparators. The most common mitigation strategy for efsitora MEIs was temporary treatment interruption (36.0%) combined with increased SMBG. Conclusion: In the phase 3 QWINT 1-4 T2D trials, MEIs were infrequent (2%) for both those taking once-weekly insulin efsitora and daily comparators. Further, of those participants who experienced MEIs, the majority completed treatment with comparable glycemic outcomes between treatment groups. Disclosure C. Mathieu: Advisory Panel; Current; Abbott Diagnostics, Dexcom, Inc. Board Member; Current; European Association for the Study of Diabetes. Advisory Panel; Current; Novo Nordisk, Eli Lilly and Company, Sanofi, Vertex Pharmaceuticals Incorporated, Medtronic. L. Connery: Advisory Panel; Current; Boehringer Ingelheim International GmbH. Research Support; Current; Boehringer Ingelheim International GmbH. Advisory Panel; Current; Eli Lilly and Company. Research Support; Current; Eli Lilly and Company, Merck Current; Novo Nordisk, Abbott Diabetes, Sanofi, CeQur SA, Amgen Inc., Xeris Pharmaceuticals, Inc., Lilly. B. Mushala: None. R. Threlkeld: Employee; Current; Eli Lilly and Company. Stock/Shareholder; Current; Eli Lilly and Company. S. Cp: None. A. Goldyn: None.
MATHIEU et al. (Fri,) studied this question.