Recruiting

Insulin Icodec vs. Basal Insulins

Sponsor:

Novo Nordisk A/S

Code:

NCT07112339

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Insulin icodec

Basal insulin analogues

Study Details

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT07112339

Start date

Aug 15, 2025

Status verified date

Aug, 2026

Completion date

Mar 23, 2028

Anticipated

Primary completion date

Mar 23, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

586 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Insulin icodec

Participants will receive subcutaneous (s.c) injection of once weekly insulin icodec.

active comparator: Basal insulin analogues

Participants will receive once daily s.c. injection of basal insulin analogues.

Interventions

Insulin icodec

Insulin icodec will be administered as subcutaneous injection.

Basal insulin analogues

Basal insulin analogues will be administered as subcutaneous injection.

Primary outcome measure

  • Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline week 0 to week 52 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

Centricity Research Calgary Endocrinology

Recruiting

Calgary, Alberta, Canada, T2H 2G4

Alta Clinical Research at Hermitage Medicentre

Recruiting

Edmonton, Alberta, Canada, T5A 4L8

Fraser Clinical Trials Inc.

Recruiting

New Westminster, British Columbia, Canada, V3L 3W4

Winnipeg Clinic

Recruiting

Winnipeg, Manitoba, Canada, R3C 0N2

G.A. Research Associates Ltd.

Recruiting

Moncton, New Brunswick, Canada, E1G 1A7

Centricity Research Brampton Endocrinology

Recruiting

Brampton, Ontario, Canada, L6S 0C6

Centricity Research Vaughn Endocrinology

Recruiting

Concord, Ontario, Canada, L4K 4M2

Centricity Research Etobicoke Endocrinology

Recruiting

Etobicoke, Ontario, Canada, M9R 4E1

Janik Research

Recruiting

Greater Sudbury, Ontario, Canada, P3C 1SB

Hamilton Medical Research Group

Recruiting

Hamilton, Ontario, Canada, L8M 1K7

St. Josephs Health Care

Recruiting

London, Ontario, Canada, N6A 4V2

Western Univ. Cnt for Studies in Fam Med

Recruiting

London, Ontario, Canada, N6G 2M1

Centricity Research Ottawa LMC

Recruiting

Nepean, Ontario, Canada, K2J 0V2

Sewa Ram Singal Medicine Professional Corp

Recruiting

Toronto, Ontario, Canada, M3N 2V6

Centricity Research Toronto

Recruiting

Toronto, Ontario, Canada, M4G 3E8

Diex Recherche Joliette

Recruiting

Joliette, Quebec, Canada, J6E 6A9

Alpha Recherche Clinique - Clinique de Levis

Recruiting

Lévis, Quebec, Canada, G6V 0C9

Centricity Research Mirabel

Recruiting

Mirabel, Quebec, Canada, J7J 2K8

Applied Medical Informatics Research

Recruiting

Montreal, Quebec, Canada, H4A 3T2

Clinique Endocrinologie OASIS.

Recruiting

Montreal, Quebec, Canada, H4J 1E3

Centricity Res Pointe-Claire

Recruiting

Pointe-Claire, Quebec, Canada, H9R 4S3

Centre de Recherche Saint-Louis

Recruiting

Sherbrooke, Quebec, Canada, J1G 1X9

Ctr de Med Metab de Lanaudiere

Recruiting

Terrebonne, Quebec, Canada, J6X 4P7

Diex Recherche Trois-Rivieres

Recruiting

Trois-Rivières, Quebec, Canada, G9A 4P3

Diex Recherche Victoriaville

Recruiting

Victoriaville, Quebec, Canada, G6P 3Z8

Recherche Clinique Sigma Inc.

Recruiting

Québec, Canada, G1G 5X1

Diex Recherche Quebec

Recruiting

Québec, Canada, G1V 4T3

Centre de Recherche Saint-Louis

Recruiting

Québec, Canada, G1W 4R4

Alpha Recherche Clinique - Lebourgneuf

Recruiting

Québec, Canada, G2J 0C4

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-08-11.