The goal of this clinical trial is to find the best way to start once-weekly insulin icodec in adults with type 2 diabetes who have not used insulin in the past 3 months, so that their fasting blood glucose reaches the target range within the first week. The main questions it aims to answer are:
* Which of three starting-dose methods brings the most people to their fasting blood glucose target by the end of the first week? * On day 4 after starting, if fasting blood glucose is still high, does giving one extra half-dose of insulin help more people reach target safely?
Participants will be randomly placed into one of three starting-dose groups: a fixed weekly dose, a dose based on their fasting blood glucose, or a dose based on their body weight. Within each group, participants will also be randomly assigned either to receive an extra insulin dose on day 4 if their fasting blood glucose is at or above a set level, or to receive no extra dose.
Participants will:
* Start once-weekly insulin icodec and continue their current non-insulin diabetes medicines * Check their fasting blood glucose, including on day 4 after starting * Wear a blinded continuous glucose monitor during the first 2 weeks and the last 2 weeks * Attend weekly visits for dose adjustment and safety checks over 12 weeks, followed by a 5-week safety follow-up
Age 18 years or older
Diagnosis of type 2 diabetes mellitus for at least 180 days
No insulin treatment of any kind within the past 3 months
Currently treated with at least one non-insulin glucose-lowering agent (oral agent or GLP-1 receptor agonist) with inadequate glycemic control, and a clinical indication to start basal insulin
Type 1 diabetes, specific types of diabetes, or recent acute complications such as diabetic ketoacidosis or hyperosmolar hyperglycemic state
Level 2 or level 3 hypoglycemia within the past 3 months, or hypoglycemia unawareness
Current use, or use within the past 3 months, of systemic glucocorticoids (excluding inhaled or topical preparations) or other agents that markedly affect blood glucose
Moderate to severe renal impairment (eGFR below 45 mL/min/1.73 m2 by the CKD-EPI 2021 creatinine equation) or need for dialysis
Factorial
Insulin icodec
DrugOnce-weekly subcutaneous insulin icodec, injected on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. The starting dose is determined by the assigned initiation strategy: a fixed 70 units per week; fasting blood glucose (mmol/L) multiplied by 7; or body weight (kg) multiplied by 0.15 and then by 7. On day 4, participants in Group A with fasting blood glucose at or above 6.8 mmol/L receive a one-time supplemental dose equal to 50% of the starting dose, while Group B receives no supplemental dose. A standardized weekly titration algorithm is applied through Week 12.
6
Treatment groupsSee each treatment group below.
Proportion of participants achieving target fasting blood glucose (4.4 to 7.0 mmol/L) at the end of Week 1
The proportion of participants whose fasting blood glucose is within the target range of 4.4 to 7.0 mmol/L, measured on the morning of Day 8 before the second weekly injection and any dose adjustment. This endpoint is compared among the three insulin icodec initiation strategies (fixed 70 U/week, FBGx7, and BWx0.15x7) to identify the strategy that best promotes early target attainment. Fasting blood glucose is assessed by capillary measurement.
Proportion of participants achieving target fasting blood glucose (4.4 to 7.0 mmol/L) at the end of Week 1, compared between the day-4 supplemental dosing decision groups (Group A vs Group B)
The effectiveness of the day-4 threshold-based supplemental dosing rule, evaluated as the proportion of participants achieving target fasting blood glucose (4.4 to 7.0 mmol/L) on the morning of Day 8. All three initiation arms are pooled, and Group A (fasting blood glucose measured on Day 4; a one-time supplemental dose equal to 50% of the starting dose given if the value is at or above 6.8 mmol/L) is compared with Group B (fasting blood glucose measured on Day 4 but no supplemental dose given). Fasting blood glucose is assessed by capillary measurement.
Absolute reduction in fasting blood glucose from baseline at the end of Week 1
The absolute change in fasting blood glucose (mmol/L) from baseline to Day 8, compared among the three initiation strategies.
Percentage reduction in fasting blood glucose from baseline at the end of Week 1
The percentage change in fasting blood glucose from baseline to Day 8, compared among the three initiation strategies.
Safe target attainment rate at the end of Week 1
The proportion of participants with fasting blood glucose within 4.4 to 7.0 mmol/L on the morning of Day 8 and without any level 2 (below 3.0 mmol/L) or level 3 hypoglycemia during Week 1.
Fasting blood glucose target attainment rate at Week 12
The proportion of participants with fasting blood glucose within 4.4 to 7.0 mmol/L at the end of Week 12.
Time to first fasting blood glucose target attainment
The number of days from initiation to the first fasting blood glucose value within the target range of 4.4 to 7.0 mmol/L.
Stability of fasting blood glucose target attainment after first reaching target
The stability of fasting blood glucose target attainment (4.4 to 7.0 mmol/L) after a participant first reaches target, assessed across subsequent weekly measurements.
Proportion of participants triggering Day-4 supplemental dosing
The proportion of participants in each initiation strategy with Day-4 fasting blood glucose at or above 6.8 mmol/L, meeting the threshold for supplemental dosing.
Incidence of adverse events and serious adverse events
The proportion of participants with adverse events and serious adverse events during the study.
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