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

NCT07112339 | Recruiting Phase 4

• 3 other identifiers: NN1436-7727U1111-1302-49432024-520068-32
• Study Type: interventional
• Target: 586
• Locations: 3 countries
• Sites: 75

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

Outcome Measures

Primary Outcomes (1)

• Change in glycated haemoglobin (HbA1c)

  Measured as %-point.

  From baseline week 0 to week 52

Secondary Outcomes (7)

• Adelphi Adherence Questionnaire (ADAQ©)

  At week 52

• Change in Diabetes Treatment Satisfaction Questionnaire- status version(DTSQs) total treatment satisfaction

  From baseline week 0 to week 52

• Treatment Related Impact Measure for Diabetes (TRIM-D) compliance domain

  At week 52

• Treatment Related Impact Measure for Diabetes (TRIM-D) treatment burden domain

  At week 52

• Number of severe hypoglycaemic episodes (level 3)

  From baseline week 0 to week 52

Study Arms (2)

Insulin icodec

EXPERIMENTAL

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

Drug: Insulin icodec

Basal insulin analogues

ACTIVE COMPARATOR

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

Drug: Basal insulin analogues

Interventions

Insulin icodec DRUG

Insulin icodec will be administered as subcutaneous injection.

Insulin icodec

Basal insulin analogues DRUG

Basal insulin analogues will be administered as subcutaneous injection.

Basal insulin analogues

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (75)

Centricity Research Calgary Endocrinology

Calgary, Alberta, T2H 2G4, Canada

RECRUITING

Alta Clinical Research at Hermitage Medicentre

Edmonton, Alberta, T5A 4L8, Canada

RECRUITING

Fraser Clinical Trials Inc.

New Westminster, British Columbia, V3L 3W4, Canada

RECRUITING

Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada

RECRUITING

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

RECRUITING

Centricity Research Brampton Endocrinology

Brampton, Ontario, L6S 0C6, Canada

RECRUITING

Centricity Clinical Research Burlington

Burlington, Ontario, L7M 4Y1, Canada

RECRUITING

Centricity Research Vaughn Endocrinology

Concord, Ontario, L4K 4M2, Canada

RECRUITING

Medical Trust Clinics, Inc.

Courtice, Ontario, L1E2J5, Canada

COMPLETED

Centricity Research Etobicoke Endocrinology

Etobicoke, Ontario, M9R 4E1, Canada

RECRUITING

Janik Research

Greater Sudbury, Ontario, P3C 1SB, Canada

RECRUITING

Premier Clinical Trial Research Network (PCTRN)

Hamilton, Ontario, L8M 1K7, Canada

RECRUITING

St. Josephs Health Care

London, Ontario, N6A 4V2, Canada

NOT YET RECRUITING

Western Univ. Cnt for Studies in Fam Med

London, Ontario, N6G 2M1, Canada

NOT YET RECRUITING

Malton Medical Clinic

Mississauga, Ontario, L4V 1P1, Canada

COMPLETED

Centricity Research Ottawa LMC

Nepean, Ontario, K2J 0V2, Canada

RECRUITING

The Ottawa Hospital_Riverside

Ottawa, Ontario, K1H7W9, Canada

NOT YET RECRUITING

Bluewater Clin Res Group Inc

Sarnia, Ontario, N7T 4X3, Canada

COMPLETED

Sewa Ram Singal Medicine Professional Corp

Toronto, Ontario, M3N 2V6, Canada

RECRUITING

Centricity Research Toronto

Toronto, Ontario, M4G 3E8, Canada

RECRUITING

Centricity Research Toronto Manna Multispec

Toronto, Ontario, M9W 4L6, Canada

COMPLETED

Diex Recherche Joliette

Joliette, Quebec, J6E 6A9, Canada

RECRUITING

Alpha Recherche Clinique - Clinique de Levis

Lévis, Quebec, G6V 0C9, Canada

RECRUITING

Centricity Research Mirabel

Mirabel, Quebec, J7J 2K8, Canada

RECRUITING

Centre hospitalier de l'Universite de Montreal

Montreal, Quebec, H2W 1R7, Canada

NOT YET RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

NOT YET RECRUITING

Applied Medical Informatics Research

Montreal, Quebec, H4A 3T2, Canada

RECRUITING

Clinique Endocrinologie OASIS.

Montreal, Quebec, H4J 1E3, Canada

RECRUITING

Centricity Res Pointe-Claire

Pointe-Claire, Quebec, H9R 4S3, Canada

RECRUITING

ALPHA Recherche Clinique

Québec, Quebec, G3K 2P8, Canada

RECRUITING

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, J1E 0N8, Canada

RECRUITING

Centre de Recherche Saint-Louis

Sherbrooke, Quebec, J1G 1X9, Canada

RECRUITING

Ctr de Med Metab de Lanaudiere

Terrebonne, Quebec, J6X 4P7, Canada

RECRUITING

Diex Recherche Trois-Rivieres

Trois-Rivières, Quebec, G9A 4P3, Canada

RECRUITING

Diex Recherche Victoriaville

Victoriaville, Quebec, G6P 6P6, Canada

RECRUITING

Recherche Clinique Sigma Inc.

Québec, G1G 5X1, Canada

RECRUITING

Diex Recherche Quebec Inc.

Québec, G1V 4T3, Canada

RECRUITING

Centre de Recherche Saint-Louis

Québec, G1W 4R4, Canada

RECRUITING

Alpha Recherche Clinique - Lebourgneuf

Québec, G2J 0C4, Canada

RECRUITING

Versidas - Diabetologikum Amberg

Amberg, Bavaria, 92224, Germany

RECRUITING

Diabetespraxis Mergentheim

Bad Mergentheim, 97980, Germany

RECRUITING

Praxis Dr. Stephan Scharla

Bad Reichenhall, 83435, Germany

NOT YET RECRUITING

Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR

Berlin, 13597, Germany

RECRUITING

Studiengesellschaft Dres. Könemann/Steinmann GbR

Bünde, 32257, Germany

RECRUITING

Diabetologische Schwerpunktpraxis Daaden

Daaden, 57567, Germany

RECRUITING

Diabeteszentrum-Do Dres. K U. Ch. Busch GbR

Dortmund, 44137, Germany

RECRUITING

Studienzentrum Dr. Faulmann GbR Dresden

Dresden, 01279, Germany

RECRUITING

MVZ Hausärzte Großenbaum GmbH Duisburg

Duisburg, 47269, Germany

RECRUITING

Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach

Eisenach, 99817, Germany

RECRUITING

MVZ Contilia GmbH

Essen, 45219, Germany

RECRUITING

Praxis am Markt Dr. Becker

Essen, 45355, Germany

RECRUITING

MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien

Fulda, 36037, Germany

RECRUITING

Diabetes-Zentrum-Wilhelmsburg GbR

Hamburg, 21109, Germany

RECRUITING

Mesut Durmaz, Hof

Hof, 95030, Germany

RECRUITING

Praxisgemeinschaft Jerichow

Jerichow, 39319, Germany

RECRUITING

Familienmedizinisches Zentrum Radowsky

Leipzig, 04179, Germany

RECRUITING

Praxis Am Oberen Tor - Dr. Simon-Wagner

Lichtenfels, 96215, Germany

RECRUITING

Diabeteszentrum Ludwigsburg

Ludwigsburg, 71634, Germany

RECRUITING

Institut für Diabetesforschung Osnabrück

Osnabrück, 49080, Germany

RECRUITING

ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim

Pohlheim, 35415, Germany

NOT YET RECRUITING

Hegau-Bodensee-Klinikum Singen

Singen, 78224, Germany

RECRUITING

Dr. Schmidt-Reinwald Astrid, Trier

Trier, 54292, Germany

RECRUITING

A.O.U. Consorziale Policlinico di Bari

Bari, BA, 70124, Italy

NOT YET RECRUITING

AOU Vanvitelli - DAI Medicina Interna, Geriatria e Neurologia - U.O.C. Endocrinologia e Malattie del Metabolismo

Naples, Campania, 80138, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Centro malattie endocrine e metaboliche

Rome, Lazio, 00168, Italy

NOT YET RECRUITING

DAI Scienze Mediche - UOC Endocrinologia

Messina, Sicily, 98124, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte

Palermo, Sicily, 90127, Italy

NOT YET RECRUITING

AST Fermo - Ospedale Murri - Unità Operativa di Diabetologia e Endocrinologia

Fermo, The Marches, 63900, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria Careggi - Diabetologia e malattie del metabolismo

Florence, Tuscany, 50134, Italy

NOT YET RECRUITING

Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia

Perugia, Umbria, 06129, Italy

NOT YET RECRUITING

Policlinico Mater Domini Università di Catanzaro

Catanzaro, 88100, Italy

NOT YET RECRUITING

Università degli studi G. D'Annunzio Chieti Pescara - CAST

Chieti Scalo, 66100, Italy

NOT YET RECRUITING

Azienda Ospedaliera Luigi Sacco

Milan, 20157, Italy

NOT YET RECRUITING

AUSL Romagna - Medicine Specialistiche Ravenna - UO Servizio di Diabetologia di Ravenna

Ravenna, 48121, Italy

NOT YET RECRUITING

Azienda Ospealiero Universitaria Policlinico Umberto I

Roma, 00161, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin icodec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 4, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (23); IT (13); CA (39)