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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorXi'an International Medical Center Hospital

About this 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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Insulin icodec

Treatment groups

462 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.