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
NCT ID: NCT07112339
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
586 participants
INTERVENTIONAL
2025-08-15
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin icodec
Participants will receive subcutaneous (s.c) injection of once weekly insulin icodec.
Insulin icodec
Insulin icodec will be administered as subcutaneous injection.
Basal insulin analogues
Participants will receive once daily s.c. injection of basal insulin analogues.
Basal insulin analogues
Basal insulin analogues will be administered as subcutaneous injection.
Interventions
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Insulin icodec
Insulin icodec will be administered as subcutaneous injection.
Basal insulin analogues
Basal insulin analogues will be administered as subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Centricity Research Calgary Endocrinology
Calgary, Alberta, Canada
Alta Clinical Research at Hermitage Medicentre
Edmonton, Alberta, Canada
Fraser Clinical Trials Inc.
New Westminster, British Columbia, Canada
Winnipeg Clinic
Winnipeg, Manitoba, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Centricity Research Brampton Endocrinology
Brampton, Ontario, Canada
Centricity Clinical Research Burlington
Burlington, Ontario, Canada
Centricity Research Vaughn Endocrinology
Concord, Ontario, Canada
Medical Trust Clinics, Inc.
Courtice, Ontario, Canada
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario, Canada
Janik Research
Greater Sudbury, Ontario, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
St. Josephs Health Care
London, Ontario, Canada
Western Univ. Cnt for Studies in Fam Med
London, Ontario, Canada
Malton Medical Clinic
Mississauga, Ontario, Canada
Centricity Research Ottawa LMC
Nepean, Ontario, Canada
The Ottawa Hospital_Riverside
Ottawa, Ontario, Canada
Bluewater Clin Res Group Inc
Sarnia, Ontario, Canada
Sewa Ram Singal Medicine Professional Corp
Toronto, Ontario, Canada
Centricity Research Toronto
Toronto, Ontario, Canada
Centricity Research Toronto Manna Multispec
Toronto, Ontario, Canada
Diex Recherche Joliette
Joliette, Quebec, Canada
Alpha Recherche Clinique - Clinique de Levis
Lévis, Quebec, Canada
Centricity Research Mirabel
Mirabel, Quebec, Canada
Centre hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Applied Medical Informatics Research
Montreal, Quebec, Canada
Clinique Endocrinologie OASIS.
Montreal, Quebec, Canada
Centricity Res Pointe-Claire
Pointe-Claire, Quebec, Canada
ALPHA Recherche Clinique
Québec, Quebec, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Centre de Recherche Saint-Louis
Sherbrooke, Quebec, Canada
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec, Canada
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, Canada
Diex Recherche Victoriaville
Victoriaville, Quebec, Canada
Recherche Clinique Sigma Inc.
Québec, , Canada
Diex Recherche Quebec Inc.
Québec, , Canada
Centre de Recherche Saint-Louis
Québec, , Canada
Alpha Recherche Clinique - Lebourgneuf
Québec, , Canada
Versidas - Diabetologikum Amberg
Amberg, Bavaria, Germany
Diabetespraxis Mergentheim
Bad Mergentheim, , Germany
Praxis Dr. Stephan Scharla
Bad Reichenhall, , Germany
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
Berlin, , Germany
Studiengesellschaft Dres. Könemann/Steinmann GbR
Bünde, , Germany
Diabetologische Schwerpunktpraxis Daaden
Daaden, , Germany
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
Dortmund, , Germany
Studienzentrum Dr. Faulmann GbR Dresden
Dresden, , Germany
MVZ Hausärzte Großenbaum GmbH Duisburg
Duisburg, , Germany
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach
Eisenach, , Germany
MVZ Contilia GmbH
Essen, , Germany
Praxis am Markt Dr. Becker
Essen, , Germany
MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
Fulda, , Germany
Diabetes-Zentrum-Wilhelmsburg GbR
Hamburg, , Germany
Mesut Durmaz, Hof
Hof, , Germany
Praxisgemeinschaft Jerichow
Jerichow, , Germany
Familienmedizinisches Zentrum Radowsky
Leipzig, , Germany
Praxis Am Oberen Tor - Dr. Simon-Wagner
Lichtenfels, , Germany
Diabeteszentrum Ludwigsburg
Ludwigsburg, , Germany
Institut für Diabetesforschung Osnabrück
Osnabrück, , Germany
ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
Pohlheim, , Germany
Hegau-Bodensee-Klinikum Singen
Singen, , Germany
Dr. Schmidt-Reinwald Astrid, Trier
Trier, , Germany
A.O.U. Consorziale Policlinico di Bari
Bari, BA, Italy
AOU Vanvitelli - DAI Medicina Interna, Geriatria e Neurologia - U.O.C. Endocrinologia e Malattie del Metabolismo
Napoli, Campania, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Centro malattie endocrine e metaboliche
Rome, Lazio, Italy
DAI Scienze Mediche - UOC Endocrinologia
Messina, Sicily, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte
Palermo, Sicily, Italy
AST Fermo - Ospedale Murri - Unità Operativa di Diabetologia e Endocrinologia
Fermo, The Marches, Italy
Azienda Ospedaliero Universitaria Careggi - Diabetologia e malattie del metabolismo
Florence, Tuscany, Italy
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
Perugia, Umbria, Italy
Policlinico Mater Domini Università di Catanzaro
Catanzaro, , Italy
Università degli studi G. D'Annunzio Chieti Pescara - CAST
Chieti Scalo, , Italy
Azienda Ospedaliera Luigi Sacco
Milan, , Italy
AUSL Romagna - Medicine Specialistiche Ravenna - UO Servizio di Diabetologia di Ravenna
Ravenna, , Italy
Azienda Ospealiero Universitaria Policlinico Umberto I
Roma, , Italy
Countries
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Central Contacts
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Other Identifiers
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U1111-1302-4943
Identifier Type: OTHER
Identifier Source: secondary_id
2024-520068-32
Identifier Type: OTHER
Identifier Source: secondary_id
NN1436-7727
Identifier Type: -
Identifier Source: org_study_id
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