TY - JOUR
T1 - 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
AU - Bajaj, Harpreet S.
AU - Aberle, Jens
AU - Davies, Melanie
AU - Donatsky, Anders Meller
AU - Frederiksen, Marie
AU - Yavuz, Dilek G.
AU - Gowda, Amoolya
AU - Lingvay, Ildiko
AU - Bode, Bruce
N1 - Publisher Copyright:
© 2023 American College of Physicians. All rights reserved.
PY - 2023/11/1
Y1 - 2023/11/1
N2 - 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 oncedaily 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.
AB - 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 oncedaily 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.
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U2 - 10.7326/M23-1288
DO - 10.7326/M23-1288
M3 - Article
C2 - 37748181
AN - SCOPUS:85178500339
SN - 0003-4819
VL - 176
SP - 1476
EP - 1485
JO - Annals of internal medicine
JF - Annals of internal medicine
IS - 11
ER -