• Harpreet S Bajaj, Jens Aberle, Melanie Davies, Anders Meller Donatsky, Marie Frederiksen, Dilek G Yavuz, Amoolya Gowda, Ildiko Lingvay, and Bruce Bode.
• LMC Diabetes and Endocrinology, Brampton, Ontario, Canada (H.S.B.).
• Ann. Intern. Med. 2023 Nov 1; 176 (11): 147614851476-1485.

BackgroundInadequate 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.ObjectiveTo 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.Design52-week, randomized, open-label, parallel-group, phase 3a trial with real-world elements. (ClinicalTrials.gov: NCT04760626).Setting176 sites in 7 countries.Participants1085 insulin-naive adults with T2D.InterventionIcodec with app or OD analogue (insulin degludec, insulin glargine U100, or insulin glargine U300).MeasurementsThe 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).ResultsThe 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.LimitationInability to differentiate the effects of icodec and the dosing guide app.ConclusionCompared with OD analogues, icodec with app showed superior HbA1c reduction and improved treatment satisfaction and compliance with similarly low hypoglycemia rates.Primary Funding SourceNovo Nordisk A/S.

21 keywords...

hide…