Clinical Trial

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

Not Yet Recruiting Phase 4
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Summary
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
Trial Details
NCT Number NCT07747402
Lead Sponsor Xi'an International Medical Center Hospital
Conditions Type 2 Diabetes
Enrollment 462 participants
Start Date 2027-01
Primary Completion 2027-10 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-05