Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2...

Area of Science:

• Endocrinology
• Metabolic Diseases
• Pharmacology

Background:

• Basal insulin therapy in type 2 diabetes (T2D) often faces challenges with dose titration and patient adherence, leading to suboptimal glycemic control.
• Once-weekly insulin icodec is an investigational basal insulin analogue designed to simplify treatment regimens and reduce patient burden.

Purpose of the Study:

• To compare the efficacy and safety of insulin icodec, when titrated using a dosing guide app, against standard once-daily basal insulin analogues in adults with T2D.
• To assess the impact of icodec with app on glycemic control, treatment satisfaction, and adherence.

Main Methods:

• A 52-week, randomized, open-label, phase 3a trial involving 1085 insulin-naive adults with T2D across 176 sites in 7 countries.
• Participants received either insulin icodec with app titration or a once-daily basal insulin analogue (insulin degludec, glargine U100, or glargine U300) per standard practice.
• Primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline to week 52; secondary endpoints included patient-reported outcomes on treatment satisfaction and adherence.

Main Results:

• Insulin icodec with app demonstrated non-inferiority and superiority in reducing HbA1c levels compared to once-daily analogues (mean difference -0.38 percentage points, P=0.009).
• Patient-reported outcomes showed greater treatment satisfaction (DTSQ) and compliance (TRIM-D) with icodec plus app.
• Rates of severe or clinically significant hypoglycemia were low and comparable between the icodec with app and once-daily analogue groups.

Conclusions:

• Once-weekly insulin icodec, when guided by a dosing app, offers superior HbA1c reduction and enhanced treatment satisfaction and adherence compared to standard once-daily basal insulins.
• The treatment regimen was associated with similarly low rates of hypoglycemia, suggesting a favorable safety profile.