Introduction and Objective: QWINT-2 met its primary endpoint, with once weekly efsitora noninferior to once-daily degludec in reducing HbA1c at 52 weeks when added to existing noninsulin glucose-lowering agents in insulin-naïve adults with T2D. A Japan subgroup analysis is shown.Methods: QWINT-2 (NCT05362058) was a phase 3, randomized, parallel-design, open-label study. Participants were randomized 1:1 to efsitora or degludec. All Japan participants were included in this analysis. Endpoints included change in HbA1c from baseline to week 52, time in glucose range (TIR) (70-180 mg/dL), and incidence and rate of level 2 (glucose <54 mg/dL) or level 3 (severe) hypoglycemia.Results: Of 144 participants, 71 were randomized to efsitora and 73 to degludec. Changes in HbA1c and TIR are shown (Figure). Incidence of level 2 or 3 hypoglycemia from weeks 0-52 was 15 (21%) with efsitora and 13 (18%) with degludec. Mean rate of level 2 or 3 hypoglycemic events per year was 0.37 (SE: 0.106) for efsitora and 0.36 (SE: 0.128) for degludec from weeks 0-52. There were two episodes of level 3 hypoglycemia with degludec from weeks 0-52. Incidence of treatment-emergent adverse events was similar across groups.Conclusion: Once-weekly efsitora was comparable to once-daily degludec in reducing HbA1c in insulin-naïve Japan participants with T2D. Efficacy and safety were consistent with the overall study population.
M. Yoshino: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. Y. Takita: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. R. Nasu: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. L. Firmino Goncalves: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. J.M. Bue-Valleskey: Employee; Eli Lilly and Company. A. Kiyosue: None.
This study was supported by Eli Lilly and Company.
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