Once-weekly insulin icodec with dosing guide app versus once-daily basal insulin analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5) : a randomized trial
Davies, Melanie
Davies, Melanie
Abstract
Background: Inadequate dose titration and poor adherence to basal insulin can lead to suboptimal glycemic control in persons with type 2 diabetes (T2D). Once-weekly insulin icodec (icodec) is a basal insulin analogue that is in development and is aimed at reducing treatment burden.
Objective: To compare the effectiveness and safety of icodec titrated with a dosing guide app (icodec with app) versus once-daily basal insulin analogues (OD analogues) dosed per standard practice.
Design: 52-week, randomized, open-label, parallel-group, phase 3a trial with real-world elements. (ClinicalTrials.gov: NCT04760626).
Setting: 176 sites in 7 countries.
Participants: 1085 insulin-naive adults with T2D.
Intervention: Icodec with app or OD analogue (insulin degludec, insulin glargine U100, or insulin glargine U300).
Measurements: The primary outcome was change in glycated hemoglobin (HbA1c) level from baseline to week 52. Secondary outcomes included patient-reported outcomes (Treatment Related Impact Measure for Diabetes [TRIM-D] compliance domain score and change in Diabetes Treatment Satisfaction Questionnaire [DTSQ] total treatment satisfaction score).
Results: The estimated mean change in HbA1c level from baseline to week 52 was greater with icodec with app than with OD analogues, with noninferiority (P < 0.001) and superiority (P = 0.009) confirmed in prespecified hierarchical testing (estimated treatment difference [ETD], -0.38 percentage points [95% CI, -0.66 to -0.09 percentage points]). At week 52, patient-reported outcomes were more favorable with icodec with app than with OD analogues (ETDs, 3.04 [CI, 1.28 to 4.81] for TRIM-D and 0.78 [CI, 0.10 to 1.47] for DTSQ). Rates of clinically significant or severe hypoglycemia were low and similar with both treatments.
Limitation: Inability to differentiate the effects of icodec and the dosing guide app.
Conclusion: Compared with OD analogues, icodec with app showed superior HbA1c reduction and improved treatment satisfaction and compliance with similarly low hypoglycemia rates.
Primary funding source: Novo Nordisk A/S.
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Date
2023-09-26
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Bajaj, H. S., Aberle, J., Davies, M., Donatsky, A. M., Frederiksen, M., Yavuz, D. G., Gowda, A., Lingvay, I., & Bode, B. (2023). Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5) : A Randomized Trial. Annals of internal medicine, 10.7326/M23-1288. Advance online publication. https://doi.org/10.7326/M23-1288