INTRODUCTION: Once-weekly efsitora resulted in similar efficacy and safety compared with daily basal insulins glargine or degludec in the treatment of adults with type 2 diabetes in the QWINT phase 3 development program. To fully assess once-weekly insulin's potential and address common barriers associated with insulin therapy (e.g., clinical inertia, fear of injections, treatment complexity), other aspects of the participants' treatment experiences were investigated using patient-reported outcome (PRO) measurements. The results of these PROs from QWINT-1 to -4 are presented here.
METHODS: Six different PRO instruments were completed across the studies at primary timepoints and treatment period endpoint (QWINT-1, week 26/52; QWINT-2, week 26/52; QWINT-3, week 26/52/78; QWINT-4, week 26) by participants enrolled in the phase 3 QWINT clinical trials. The PRO instruments included Treatment Related Impact Measure-Diabetes (Trim-D) (QWINT-1, -2, and -3), Diabetes Treatment Satisfaction Questionnaire (DTSQ) (QWINT-1 and -3), Simplicity of Diabetes Treatment Questionnaire (SIM-Q) (QWINT-1, -2, and -3), Basal Insulin Experience (BIE) (all QWINTs), EQ-5D-5L (QWINT-2, -3, and -4), and Short Form-36 Health Survey Version 2(SF-36v2) (QWINT-2).
RESULTS: Efsitora-treated participants demonstrated greater or similar improvements than comparators for most of the measured PROs at the primary timepoint in all four studies, particularly in QWINT-3 and -4 (prior insulin experience). Notably, for those treated with efsitora, there were significantly larger improvements than comparators in the PRO domains of treatment burden, daily life, diabetes management, compliance, satisfaction, and psychological health, as measured using the TRIM-D and DTSQc. Participants treated with efsitora had similar scores across both health-related quality of life measures, EQ-5D-5L and SF-36v2, at the primary endpoint when evaluated versus the comparator.
CONCLUSIONS: Participants in the QWINT-1 to -4 studies demonstrated a strong preference for efsitora, along with improved overall functioning, well-being, and treatment burden compared to daily basal insulins.
CLINICAL TRIAL REGISTRATION NUMBER FOR QWINT STUDIES: QWINT-1: NCT05662332; QWINT-2: NCT05362058; QWINT-3: NCT05275400; QWINT-4: NCT05462756.
Insulin efsitora alfa (efsitora) is an innovative once-weekly basal insulin treatment evaluated in the Phase 3 QWINT clinical trials. The QWINT -1 to -4 clinical trials evaluated the efficacy and safety of efsitora, and the experience of adults with type 2 diabetes (T2D) treated with efsitora compared to daily insulin treatments. Efsitora had similar glycemic control and safety compared to daily basal insulin. Furthermore, patient-reported outcomes (PROs) showed greater improvements in treatment burden and satisfaction with efsitora, which was preferred more often compared to daily basal insulin. The PROs included six questionnaires: Treatment Related Impact Measure-Diabetes (TRIM-D) (QWINT-1, -2, and -3) measuring impact of diabetes treatment on a person’s functioning, wellbeing, and satisfaction with diabetes therapy; Diabetes Treatment Satisfaction Questionnaire (DTSQ) (QWINT-1, and -3) assessing treatment satisfaction; Simplicity of Diabetes Treatment Questionnaire (SIM-Q) (QWINT-1, -2, and -3) measuring simplicity of the treatment; Basal Insulin Experience (BIE) to evaluate participants’ preference (QWINT-3, and -4) for their insulin treatment and likelihood (all QWINTs) of incorporating into their diabetes management routine; EQ-5D-5L (QWINT-2,-3, and -4) measuring overall quality of life; and Short Form-36 Version 2 Health Survey Acute Form (SF-36v2) (QWINT-2) assessing health across eight domains. Participants reported that they would be very likely to incorporate efsitora into their diabetes management routine. With the positive results from the QWINT trials and strong PRO preferences, efsitora shows promise for treating people with T2D.
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