Insulin Icodec Initiation Strategies and Day-4 Supplemental Dosing in Type 2 Diabetes

Sponsor
Xi'an International Medical Center Hospital
Study ID
NCT07747402
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Insulin icodec — DRUG
    Once-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.

Study Details

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

Key Dates

First listed
Aug 5, 2026
Start date
Jan 31, 2027
Status verified
Jul 2026
Primary completion
Oct 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
462 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fixed 70 U/Week + Day-4 Supplement (Group A)
    Insulin icodec is initiated at a fixed dose of 70 units once weekly, injected subcutaneously on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. On day 4, fasting blood glucose is measured; if it is at or above 6.8 mmol/L, a one-time supplemental dose equal to 50% of the starting dose (35 units) is given that day. For participants who received the supplemental dose, the day 8 dose returns to the starting dose, and a standardized weekly titration algorithm is applied from day 15 through Week 12.
  • Active Comparator: Fixed 70 U/Week + No Day-4 Supplement (Group B)
    Insulin icodec is initiated at a fixed dose of 70 units once weekly, injected subcutaneously on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. On day 4, fasting blood glucose is measured for recording only; no supplemental dose is given. A standardized weekly titration algorithm is applied from day 8 through Week 12.
  • Experimental: FBG-Based Dose (FBG×7) + Day-4 Supplement (Group A)
    Insulin icodec is initiated at a dose calculated as fasting blood glucose (mmol/L) multiplied by 7, given once weekly, injected subcutaneously on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. On day 4, fasting blood glucose is measured; if it is at or above 6.8 mmol/L, a one-time supplemental dose equal to 50% of the starting dose is given that day. For participants who received the supplemental dose, the day 8 dose returns to the starting dose, and a standardized weekly titration algorithm is applied from day 15 through Week 12.
  • Experimental: FBG-Based Dose (FBG×7) + No Day-4 Supplement (Group B)
    Insulin icodec is initiated at a dose calculated as fasting blood glucose (mmol/L) multiplied by 7, given once weekly, injected subcutaneously on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. On day 4, fasting blood glucose is measured for recording only; no supplemental dose is given. A standardized weekly titration algorithm is applied from day 8 through Week 12.
  • Experimental: Weight-Based Dose (BW×0.15×7) + Day-4 Supplement (Group A)
    Insulin icodec is initiated at a dose calculated as body weight (kg) multiplied by 0.15 and then by 7, given once weekly, injected subcutaneously on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. On day 4, fasting blood glucose is measured; if it is at or above 6.8 mmol/L, a one-time supplemental dose equal to 50% of the starting dose is given that day. For participants who received the supplemental dose, the day 8 dose returns to the starting dose, and a standardized weekly titration algorithm is applied from day 15 through Week 12.
  • Experimental: Weight-Based Dose (BW×0.15×7) + No Day-4 Supplement (Group B)
    Insulin icodec is initiated at a dose calculated as body weight (kg) multiplied by 0.15 and then by 7, given once weekly, injected subcutaneously on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. On day 4, fasting blood glucose is measured for recording only; no supplemental dose is given. A standardized weekly titration algorithm is applied from day 8 through Week 12.

Primary Outcome Measure

Proportion of participants achieving target fasting blood glucose (4.4 to 7.0 mmol/L) at the end of Week 1 [ Time Frame: Day 8 (end of Week 1) ]

Central Contacts

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