RecruitingPhase 4NCT07112339

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

Sponsor

Novo Nordisk A/S

Enrollment

586 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing weekly insulin icodec — a new long-acting insulin that only needs to be injected once a week instead of daily — in people with type 2 diabetes who need to start insulin therapy. Researchers want to see how well it maintains blood sugar control compared to daily insulin options. **You may be eligible if...** - You have been diagnosed with type 2 diabetes for at least 6 months - You are currently taking oral diabetes medications (such as metformin, SGLT2 inhibitors, DPP-4 inhibitors, GLP-1 receptor agonists, or others) and need to add basal insulin - Your HbA1c (3-month average blood sugar level) is 7% or above within the last 90 days - Your doctor believes you need insulin to better control your blood sugar **You may NOT be eligible if...** - You are allergic to the study drugs - You have type 1 diabetes - You are pregnant, breastfeeding, or planning to become pregnant - You have had severe low blood sugar episodes (level 3 hypoglycemia) in the past - You are currently on insulin therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInsulin icodec

Insulin icodec will be administered as subcutaneous injection.

DRUGBasal insulin analogues

Basal insulin analogues will be administered as subcutaneous injection.

Locations(75)

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

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

Québec, Canada

Centre de Recherche Saint-Louis

Québec, Canada

Alpha Recherche Clinique - Lebourgneuf

Québec, Canada

Versdias - 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

Azienda Ospedaliero Universitaria Renato Dulbecco - Mater Domini

Catanzaro, Calabria, Italy

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

Naples, Campania, Italy

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

Rome, Lazio, Italy

DAI Scienze Mediche - UOSD Diabetologia

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

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

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NCT07112339

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