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NCT07112339RecruitingPhase 4

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

EFFectiveness of Once-weekly Insulin ICodec Versus Once-daily Basal Insulin Analogues in an Insulin-naïve Type 2 diabEtes Population in Real-world cliNical pracTice- The EFFICIENT Pragmatic Study Effectiveness of Insulin Icodec in Real-world Clinical Practice

Source: ClinicalTrials.gov · Last updated 11 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
586 (estimated)
First submitted
1 Aug 2025
Start date
15 Aug 2025
Primary completion date
23 Mar 2028
Lead sponsor
Novo Nordisk A/S
NCT number
NCT07112339
EU CT number
2024-520068-32-00
EudraCT number
2024-520068-32

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 586
  • From 15 Aug 2025 to the primary completion date, 23 Mar 2028
  • 75 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous participation in this study. Participation is defined as signed informed consent.
  • Participation (i.e., received any study intervention) in any interventional clinical study within 90 days before screening.

Other illness

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Any disorder which in the investigator's opinion might jeopardize participant's safety.

Other

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (75)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centricity Research Brampton Endocrinology
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BramptonCanadaRecruiting
Centricity Clinical Research Burlington
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BurlingtonCanadaCompleted
Centricity Research Calgary Endocrinology
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CalgaryCanadaRecruiting
Centricity Research Vaughn Endocrinology
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ConcordCanadaRecruiting
Medical Trust Clinics, Inc.
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CourticeCanadaCompleted
Alta Clinical Research at Hermitage Medicentre
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EdmontonCanadaRecruiting
Centricity Research Etobicoke Endocrinology
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EtobicokeCanadaRecruiting
Janik Research
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Greater SudburyCanadaRecruiting
Hamilton Medical Research Group
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HamiltonCanadaRecruiting
Diex Recherche (Joliette)
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JolietteCanadaRecruiting
Alpha Recherche Clinique - Clinique de Levis
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LévisCanadaRecruiting
Western Univ. Cnt for Studies in Fam Med
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LondonCanadaRecruiting
St. Josephs Health Care
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LondonCanadaRecruiting
Centricity Research Mirabel
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MirabelCanadaRecruiting
Malton Medical Clinic
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MississaugaCanadaCompleted
G.A. Research Associates, Ltd.
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MonctonCanadaRecruiting
Clinique Endocrinologie OASIS.
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MontrealCanadaRecruiting
Centre Hospitalier de l'Université de Montréal
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MontrealCanadaNot yet recruiting
Applied Medical Informatics Research
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MontrealCanadaRecruiting
McGill University Health Centre
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MontrealCanadaNot yet recruiting
Centricity Research Ottawa LMC
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NepeanCanadaRecruiting
Fraser Clinical Trials, Inc.
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New WestminsterCanadaRecruiting
The Ottawa Hospital_Riverside
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OttawaCanadaNot yet recruiting
Centricity Res Pointe-Claire
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Pointe-ClaireCanadaRecruiting
Centre de Recherche Saint-Louis
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QuébecCanadaRecruiting
Alpha Recherche Clinique - Lebourgneuf
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QuébecCanadaRecruiting
Recherche Clinique Sigma inc
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QuébecCanadaRecruiting
Diex Recherche Québec
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QuébecCanadaRecruiting
Alpha Recherche Clinique
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QuébecCanadaCompleted
Bluewater Clin Res Group Inc
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SarniaCanadaCompleted
Centre de Recherche Saint-Louis
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SherbrookeCanadaRecruiting
Diex Recherche Sherbrooke
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SherbrookeCanadaCompleted
Ctr de Med Metab de Lanaudiere
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TerrebonneCanadaRecruiting
Centricity Research Toronto Manna Multispec
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TorontoCanadaCompleted
Centricity Research Toronto
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TorontoCanadaRecruiting
Sewa Ram Singal Medicine Professional Corp
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TorontoCanadaRecruiting
Diex Recherche Trois-Rivieres
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Trois-RivièresCanadaRecruiting
Diex Recherche Victoriaville
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VictoriavilleCanadaRecruiting
Winnipeg Clinic
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WinnipegCanadaRecruiting
Versdias GmbH
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AmbergGermanyNot yet recruiting
MVZ DiaMedicum Bad Mergentheim GmbH
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Bad MergentheimGermanyNot yet recruiting
Praxis Dr. Stephan Scharla
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Bad ReichenhallGermanyNot yet recruiting
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
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BerlinGermanyNot yet recruiting
Studiengesellschaft Drs Könemann / Steinmann
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BündeGermanyNot yet recruiting
Diabetologische Schwerpunktpraxis Daaden
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DaadenGermanyNot yet recruiting
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
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DortmundGermanyNot yet recruiting
Studienzentrum Dr. Faulmann GbR
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DresdenGermanyNot yet recruiting
MVZ Hausärzte Großenbaum GmbH
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DuisburgGermanyNot yet recruiting
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach
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EisenachGermanyNot yet recruiting
Praxis am Markt Dr. Becker
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EssenGermanyNot yet recruiting
MVZ Contilia GmbH - Studienzentrum Diabetologie
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EssenGermanyNot yet recruiting
MVZ im Altstadt-Carree Fulda GmbH
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FuldaGermanyNot yet recruiting
Diabetes Zentrum Wilhelmsburg GbR
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HamburgGermanyNot yet recruiting
Mesut Durmaz Schwerpunktpraxis für Diabetes, Hormone & Stoffwechsel Studienzentrum
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HofGermanyNot yet recruiting
Praxisgemeinschaft Jerichow Schulze
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JerichowGermanyNot yet recruiting
Familienmedizinisches Zentrum Radowsky
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LeipzigGermanyNot yet recruiting
Praxis Am Oberen Tor
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LichtenfelsGermanyNot yet recruiting
Diabeteszentrum Ludwigsburg
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LudwigsburgGermanyNot yet recruiting
Institut für Diabetesforschung Osnabrück
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OsnabrückGermanyNot yet recruiting
Centrum Fuer Diabetologie Und Allgemeinmedizin
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PohlheimGermanyNot yet recruiting
Gesundheitsverbund Landkreis Konstanz gGmbH
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Singen (Hohentwiel)GermanyNot yet recruiting
Praxis Dr. Astrid Schmidt-Reinwald
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TrierGermanyNot yet recruiting
University Of Bari Aldo Moro
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BariItalyNot yet recruiting
Azienda Ospedaliero Universitaria Renato Dulbecco
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CatanzaroItalyNot yet recruiting
Universita' Degli Studi G. D'Annunzio Di Chieti
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Chieti ScaloItalyNot yet recruiting
Azienda Sanitaria Territoriale Di Fermo
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FermoItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyNot yet recruiting
Azienda Ospedaliera Universitaria Gaetano Martino Messina
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MessinaItalyNot yet recruiting
ASST Fatebenefratelli Sacco
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MilanItalyNot yet recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyNot yet recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyNot yet recruiting
Hospital Santa Maria Della Misericordia
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PerugiaItalyNot yet recruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyNot yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.