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

Trial details

Who runs it

Xi'an International Medical Center Hospital

Trial code

NCT07747402

Record updated

5 August 2026

Original description

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:Read full original descriptionShow less

Effects of Different Insulin Icodec Initiation Strategies and a Day-4 Supplemental Dosing Decision on Early Fasting Blood Glucose Target Attainment in Type 2 Diabetes: A Multicenter, Randomized, Open-Label, 3x2 Factorial Trial

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

Inclusion: 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: Participation in another drug or device clinical trial within the past 3 months; Type 1 diabetes, specific types of diabetes, or recent acute complications such as diabetic ketoacidosis or hyperosmolar hyperglycemic state; 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; 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; Other conditions judged by the investigator to be unsuitable for enrollment or likely to affect participant safety or data reliability; 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; Extensive skin lesions, allergy to continuous glucose monitor adhesive, or anticipated frequent magnetic resonance imaging that may interfere with monitor wear or interpretation; Level 2 or level 3 hypoglycemia within the past 3 months, or hypoglycemia unawareness; Pregnancy or lactation, or women of childbearing potential with pregnancy plans.

ClinicalTrials.gov NCT07747402