RecruitingPhase 4

A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes

Canada, Germany, Italy586 participantsStarted 2025-08-15

Plain-language summary

This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable weekly insulin icodec maintains blood sugar levels when compared to approved and available daily injectable basal insulins in people with type 2 diabetes. The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for the treatment of type 2 diabetes. The study will last for about 13 months.

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: * Diagnosed with T2D greater than or equal to (≥) 180 days prior to the day of screening. * Treatment with any of the following non-insulin glucose-lowering medication(s) or combination regimen(s) at the time of screening: Metformin, Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs), Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists and Injectable dual glucose-dependent insulinotropic polypeptides (GIP) and GLP-1 receptor agonist. * Need of intensification with basal insulin, as indicated at the discretion of the investigator. * Recorded HbA1c value ≥7% within the last 90 days prior to randomization. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Previous participation in this study. Participation is defined as signed informed consent. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method. * Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening. * Any disorder which in the investigator's opinion might jeopardize participant's safety.

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.

1Since this is a Phase 4 trial, insulin icodec has already been approved — but how does the evidence from this study comparing it to daily basal insulins apply to my specific situation with Type 2 diabetes?
2The main thing this study is measuring is change in HbA1c — based on where my HbA1c currently sits, do you think switching to a once-weekly insulin like icodec is likely to make a meaningful difference for me compared to staying on a daily basal insulin?
3A once-weekly injection schedule sounds appealing, but are there any known risks or side effects with insulin icodec — like hypoglycemia — that I should weigh carefully before considering this trial?
4Would joining this study require me to change or stop any diabetes medications I'm currently taking, and how might that affect my blood sugar management during the trial period?
5Is there a standard daily basal insulin option that you'd recommend for me right now, and would it make more sense to try that first rather than enrolling in a research study?

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

Change in glycated haemoglobin (HbA1c)

Timeframe: From baseline week 0 to week 52

Trial details

NCT IDNCT07112339

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-04

Contact for this trial

Novo Nordisk

(+1) 866-867-7178 clinicaltrials@novonordisk.com

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials