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

Recruiting now · Phase 4

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT07112339

Run by

Novo Nordisk A/S

People needed

586

Starts

2025-08-15

Expected to finish

2028-08-31

Last updated by the study team

2026-06-05

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Centre de Recherche Saint-Louis — Sherbrooke, Quebec, Canada (enrolling)
• Diex Recherche Trois-Rivieres — Trois-Rivières, Quebec, Canada (enrolling)
• Clinique Endocrinologie OASIS. — Montreal, Quebec, Canada (enrolling)
• Centricity Res Pointe-Claire — Pointe-Claire, Quebec, Canada (enrolling)
• Ctr de Med Metab de Lanaudiere — Terrebonne, Quebec, Canada (enrolling)
• Centricity Research Calgary Endocrinology — Calgary, Alberta, Canada (enrolling)
• Alta Clinical Research at Hermitage Medicentre — Edmonton, Alberta, Canada (enrolling)
• Applied Medical Informatics Research — Montreal, Quebec, Canada (enrolling)
• G.A. Research Associates Ltd. — Moncton, New Brunswick, Canada (enrolling)
• Janik Research — Greater Sudbury, Ontario, Canada (enrolling)
• Centricity Research Brampton Endocrinology — Brampton, Ontario, Canada (enrolling)
• St. Josephs Health Care — London, Ontario, Canada (enrolling)
• Western Univ. Cnt for Studies in Fam Med — London, Ontario, Canada (enrolling)
• Fraser Clinical Trials Inc. — New Westminster, British Columbia, Canada (enrolling)
• Centricity Research Ottawa LMC — Nepean, Ontario, Canada (enrolling)
• Centricity Research Vaughn Endocrinology — Concord, Ontario, Canada (enrolling)
• Winnipeg Clinic — Winnipeg, Manitoba, Canada (enrolling)
• Sewa Ram Singal Medicine Professional Corp — Toronto, Ontario, Canada (enrolling)
• Centricity Research Toronto — Toronto, Ontario, Canada (enrolling)
• Centricity Research Etobicoke Endocrinology — Etobicoke, Ontario, Canada (enrolling)
• Diex Recherche Joliette — Joliette, Quebec, Canada (enrolling)
• Alpha Recherche Clinique - Clinique de Levis — Lévis, Quebec, Canada (enrolling)
• Centricity Research Mirabel — Mirabel, Quebec, Canada (enrolling)
• Premier Clinical Trial Research Network (PCTRN) — Hamilton, Ontario, Canada (enrolling)
• Diex Recherche Victoriaville — Victoriaville, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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