Hideaki Jinnouchi, Mariko Inoue, Yasushi Takita, Risa Nasu, Rebecca Threlkeld
Once-weekly efsitora was similar to once-daily degludec in lowering HbA1c in Japanese QWINT-3 participants with T2D already receiving daily basal insulin. Efficacy and safety were consistent with the overall QWINT-3 study population. This subgroup analysis suggests that efsitora is well tolerated and effective as a once-weekly basal insulin in Japanese adults with T2D inadequately controlled with daily basal insulin.
INTRODUCTION: The phase 3 QWINT-3 study demonstrated that once-weekly insulin efsitora (efsitora) was noninferior to once-daily insulin degludec (degludec) in reducing glycated hemoglobin A1c (HbA1c) at week 26 (primary end point) in adults with type 2 diabetes (T2D) who had previously received insulin. A subgroup analysis of QWINT-3 participants from Japan is presented.
METHODS: QWINT-3 was a phase 3, multicenter, randomized, parallel-design, open-label study. Participants were randomized in a 2:1 ratio to receive efsitora or degludec. All participants from Japan were included in this preplanned subgroup analysis. End points investigated included changes in HbA1c from weeks 0 to 26 and throughout the treatment period (weeks 0-78), time spent in the glucose range from weeks 22 to 26 and during the initial dosing period (weeks 0-12), fasting blood glucose from weeks 0 to 78, and incidence and rate of hypoglycemia from weeks 0 to 78.
RESULTS: Overall, 131 participants from Japan were randomized to efsitora (n = 87) or degludec (n = 44). Demographics and baseline characteristics were balanced between treatment groups. From weeks 0 to 26, HbA1c decreased from 7.64% to 6.82% in the efsitora group and from 7.56% to 7.13% in the degludec group (estimated treatment difference: -0.31% [95% confidence interval (CI), -0.57 to -0.05]). Rates of level 2 or level 3 hypoglycemic events were generally low and similar between efsitora and degludec. From weeks 0 to 78, one severe hypoglycemic event was reported for efsitora; none were reported for degludec.
CONCLUSIONS: Once-weekly efsitora was similar to once-daily degludec in lowering HbA1c in Japanese QWINT-3 participants with T2D already receiving daily basal insulin. Efficacy and safety were consistent with the overall QWINT-3 study population. This subgroup analysis suggests that efsitora is well tolerated and effective as a once-weekly basal insulin in Japanese adults with T2D inadequately controlled with daily basal insulin.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05275400.