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Introduction <p>The phase 3 QWINT-2 study demonstrated that once-weekly insulin efsitora alfa (efsitora) was noninferior to once-daily insulin degludec (degludec) in reducing glycated hemoglobin (HbA1c) at week 52 when added to existing noninsulin glucose-lowering agents in adults with type 2 diabetes who were insulin-naïve. A Japan subgroup analysis of QWINT-2 using two dosing algorithms is presented here.</p> Methods <p>Participants from Japan were randomized 1:1 to efsitora or degludec and followed one of two dosing algorithms: a general dosing algorithm or an optional alternative dosing algorithm available for participants anticipated to require less insulin, characterized by a body weight ≤ 60&#xa0;kg or HbA1c level ≤ 7.5% at baseline. Assessments included changes in HbA1c and fasting blood glucose from weeks 0–52, time spent in target glucose range (TIR) from weeks 48–52, and hypoglycemia from weeks 0–52.</p> Results <p>In total, 144 participants from Japan were included (efsitora, <i>n</i> = 71; degludec, <i>n</i> = 73). Demographic and baseline characteristics were generally balanced between treatment groups. From weeks 0–52, mean HbA1c decreased from 8.04% to 6.63% with efsitora and from 8.00% to 6.64% with degludec (estimated treatment difference, −0.01%). TIR was similar between efsitora and degludec from weeks 48–52. Rates of combined level 2 or 3 hypoglycemia were low overall (weeks 0–52) and during the initial dosing period (weeks 0–12). Level 3 hypoglycemia was not reported in any participants with efsitora and two participants with degludec. The incidence of adverse events was similar between efsitora and degludec. The efficacy and safety of efsitora were comparable with degludec using the general and alternative dosing algorithms in Japanese participants.</p> Conclusions <p>Once-weekly efsitora was comparable to once-daily degludec in reducing HbA1c in Japanese participants who were insulin-naïve. The efficacy and safety of efsitora in Japanese participants were consistent with the overall QWINT-2 study population.</p> ClinicalTrials.gov Identifier <p>NCT05362058.</p>

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Efficacy and Safety of Insulin Efsitora Versus Degludec in Adults with Type 2 Diabetes Who Are Insulin-Naïve: Japan Subgroup Analysis of QWINT-2

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  • 发表日期：

    2026年5月24日

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  • Arihiro Kiyosue,
  • Mariko Inoue,
  • Yasushi Takita,
  • Risa Nasu,
  • Hirotaka Watada

摘要

Introduction

The phase 3 QWINT-2 study demonstrated that once-weekly insulin efsitora alfa (efsitora) was noninferior to once-daily insulin degludec (degludec) in reducing glycated hemoglobin (HbA1c) at week 52 when added to existing noninsulin glucose-lowering agents in adults with type 2 diabetes who were insulin-naïve. A Japan subgroup analysis of QWINT-2 using two dosing algorithms is presented here.

Methods

Participants from Japan were randomized 1:1 to efsitora or degludec and followed one of two dosing algorithms: a general dosing algorithm or an optional alternative dosing algorithm available for participants anticipated to require less insulin, characterized by a body weight ≤ 60 kg or HbA1c level ≤ 7.5% at baseline. Assessments included changes in HbA1c and fasting blood glucose from weeks 0–52, time spent in target glucose range (TIR) from weeks 48–52, and hypoglycemia from weeks 0–52.

Results

In total, 144 participants from Japan were included (efsitora, n = 71; degludec, n = 73). Demographic and baseline characteristics were generally balanced between treatment groups. From weeks 0–52, mean HbA1c decreased from 8.04% to 6.63% with efsitora and from 8.00% to 6.64% with degludec (estimated treatment difference, −0.01%). TIR was similar between efsitora and degludec from weeks 48–52. Rates of combined level 2 or 3 hypoglycemia were low overall (weeks 0–52) and during the initial dosing period (weeks 0–12). Level 3 hypoglycemia was not reported in any participants with efsitora and two participants with degludec. The incidence of adverse events was similar between efsitora and degludec. The efficacy and safety of efsitora were comparable with degludec using the general and alternative dosing algorithms in Japanese participants.

Conclusions

Once-weekly efsitora was comparable to once-daily degludec in reducing HbA1c in Japanese participants who were insulin-naïve. The efficacy and safety of efsitora in Japanese participants were consistent with the overall QWINT-2 study population.

ClinicalTrials.gov Identifier

NCT05362058.