Not Yet RecruitingPhase 4

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

China462 participantsStarted 2027-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * HbA1c of 7.0% to 11.0% at screening * Body mass index of 35.0 kg/m2 or lower * Able and willing to wear a continuous glucose monitor per protocol, to undergo day-4 fasting blood glucose assessment, and to attend all scheduled visits * Provides written informed consent Exclusion Criteria: * 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 * Active liver disease, abnormal liver function (ALT or AST above 3 times the upper limit of normal), or decompensated cirrhosis * Marked edema, large-volume ascites, amputation, or other conditions that may impair accurate body weight measurement or distort weight-based dosing * Known allergy to insulin icodec …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing a once-weekly insulin called icodec with a possible extra 'supplemental' dose on day 4 of the first week — how does that differ from how I would manage my insulin if I just started standard daily insulin treatment right now?
2Since this trial is Phase 4, which means icodec has already been approved, does that change what my doctor already knows about its safety, and are there still meaningful unknowns about these specific dosing strategies that make the trial relevant for me?
3The trial hasn't started recruiting yet — do you know roughly when it will open, and is waiting for it a realistic option given where my blood sugar control stands right now?
4The main thing this trial is measuring is whether people hit a target fasting blood sugar range in just the first week — what happens to my care and insulin management after that initial week if I were to participate?
5Would I be a good candidate to discuss this trial with the study team, or do you think starting an established insulin regimen now would be a safer or faster path to getting my type 2 diabetes under better control?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of participants achieving target fasting blood glucose (4.4 to 7.0 mmol/L) at the end of Week 1

Timeframe: Day 8 (end of Week 1)

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)

Timeframe: Day 8 (end of Week 1)

Trial details

NCT IDNCT07747402

SponsorXi'an International Medical Center Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Tao Liu

86-29-68301145 neifenmi@163.com

View on ClinicalTrials.gov More Type 2 Diabetes trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of participants achieving target fasting blood glucose (4.4 to 7.0 mmol/L) at the end of Week 1

Timeframe: Day 8 (end of Week 1)

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)

Timeframe: Day 8 (end of Week 1)