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

Starting soon · Phase 4

Conditions studied: Type 2 Diabetes

In brief

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 facts

Study ID: NCT07747402
Run by: Xi'an International Medical Center Hospital
People needed: 462
Starts: 2027-01-01
Expected to finish: 2028-03-01
Last updated by the study team: 2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 or its excipients
Extensive skin lesions, allergy to continuous glucose monitor adhesive, or anticipated frequent magnetic resonance imaging that may interfere with monitor wear or interpretation
Active malignancy
Acute cardiovascular or cerebrovascular event (such as myocardial infarction, stroke, or unstable angina) within the past 6 months, or other major illness with short expected survival or poor compliance
Pregnancy or lactation, or women of childbearing potential with pregnancy plans
Participation in another drug or device clinical trial within the past 3 months
Other conditions judged by the investigator to be unsuitable for enrollment or likely to affect participant safety or data reliability

Where it is running

Xi'an International Medical Center Hospital — Xi'an, Shaanxi, China

Full record on ClinicalTrials.gov

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