Once-weekly insulin icodec versus daily basal insulin for adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4, post-approval comparison assigns adults with type 2 diabetes who need basal insulin intensification to receive either once-weekly insulin icodec or a commonly used daily basal insulin and follows them for about 13 months. Participants may continue allowed non-insulin glucose-lowering medications and will have regular clinic visits to monitor blood sugar control and safety. Key outcomes include HbA1c maintenance and rates of hypoglycemia and other adverse events. The trial is being run at several clinical research sites in Canada.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centricity Research Calgary Endocrinology
  Calgary, Alberta, Canada Recruiting
• Alta Clinical Research at Hermitage Medicentre
  Edmonton, Alberta, Canada Recruiting
• Fraser Clinical Trials Inc.
  New Westminster, British Columbia, Canada Recruiting
• Winnipeg Clinic
  Winnipeg, Manitoba, Canada Recruiting
• G.A. Research Associates Ltd.
  Moncton, New Brunswick, Canada Recruiting
• Centricity Research Brampton Endocrinology
  Brampton, Ontario, Canada Recruiting

+25 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.