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

Status: Recruiting
Location: See all (75) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Centricity Research Brampton
RECRUITING
Brampton
Centricity Clinical Research Burlington
RECRUITING
Burlington
Centricity Research Calgary
NOT_YET_RECRUITING
Calgary
Centricity Research Vaughn Endocrinology
RECRUITING
Concord
Medical Trust Clinics, Inc.
WITHDRAWN
Courtice
Alta Clinical Research at Hermitage Medicentre
NOT_YET_RECRUITING
Edmonton
Centricity Research Etobicoke
RECRUITING
Etobicoke
Janik Research
RECRUITING
Greater Sudbury
Premier Clinical Trial Research Network (PCTRN)
RECRUITING
Hamilton
Diex Recherche Joliette
RECRUITING
Joliette
Alpha Recherche Clinique - Clinique de Levis
RECRUITING
Lévis
St. Josephs Health Care
NOT_YET_RECRUITING
London
Western Univ. Cnt for Studies in Fam Med
NOT_YET_RECRUITING
London
Centricity Research Mirabel
RECRUITING
Mirabel
Malton Medical Clinic
WITHDRAWN
Mississauga
G.A. Research Associates Ltd.
RECRUITING
Moncton
Applied Medical Informatics Research
RECRUITING
Montreal
Centre hospitalier de l'Universite de Montreal
NOT_YET_RECRUITING
Montreal
Clinique Endocrinologie OASIS.
RECRUITING
Montreal
McGill University Health Centre
NOT_YET_RECRUITING
Montreal
Centricity Research Ottawa LMC
RECRUITING
Nepean
Fraser Clinical Trials Inc.
RECRUITING
New Westminster
The Ottawa Hospital_Riverside
NOT_YET_RECRUITING
Ottawa
Centricity Res Pointe-Claire
RECRUITING
Pointe-claire
ALPHA Recherche Clinique
RECRUITING
Québec
Alpha Recherche Clinique - Lebourgneuf
RECRUITING
Québec
Centre de Recherche Saint-Louis
RECRUITING
Québec
Diex Recherche Quebec Inc.
RECRUITING
Québec
Recherche Clinique Sigma Inc.
RECRUITING
Québec
Bluewater Clin Res Group Inc
WITHDRAWN
Sarnia
Centre de Recherche Saint-Louis
NOT_YET_RECRUITING
Sherbrooke
Diex Recherche Sherbrooke Inc.
NOT_YET_RECRUITING
Sherbrooke
Ctr de Med Metab de Lanaudiere
RECRUITING
Terrebonne
Centricity Research Toronto
RECRUITING
Toronto
Centricity Research Toronto Manna Multispec
NOT_YET_RECRUITING
Toronto
Sewa Ram Singal Medicine Professional Corp
RECRUITING
Toronto
Diex Recherche Trois-Rivieres
RECRUITING
Trois-rivières
Diex Recherche Victoriaville
RECRUITING
Victoriaville
Winnipeg Clinic
RECRUITING
Winnipeg
Germany
Versidas - Diabetologikum Amberg
RECRUITING
Amberg
Diabetespraxis Mergentheim
RECRUITING
Bad Mergentheim
Praxis Dr. Stephan Scharla
NOT_YET_RECRUITING
Bad Reichenhall
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
RECRUITING
Berlin
Studiengesellschaft Dres. Könemann/Steinmann GbR
NOT_YET_RECRUITING
Bünde
Diabetologische Schwerpunktpraxis Daaden
RECRUITING
Daaden
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
RECRUITING
Dortmund
Studienzentrum Dr. Faulmann GbR Dresden
NOT_YET_RECRUITING
Dresden
MVZ Hausärzte Großenbaum GmbH Duisburg
RECRUITING
Duisburg
Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach
RECRUITING
Eisenach
MVZ Contilia GmbH
RECRUITING
Essen
Praxis am Markt Dr. Becker
NOT_YET_RECRUITING
Essen
MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
RECRUITING
Fulda
Diabetes-Zentrum-Wilhelmsburg GbR
RECRUITING
Hamburg
Mesut Durmaz, Hof
RECRUITING
Hof
Praxisgemeinschaft Jerichow
RECRUITING
Jerichow
Familienmedizinisches Zentrum Radowsky
RECRUITING
Leipzig
Praxis Am Oberen Tor - Dr. Simon-Wagner
RECRUITING
Lichtenfels
Diabeteszentrum Ludwigsburg
RECRUITING
Ludwigsburg
Institut für Diabetesforschung Osnabrück
NOT_YET_RECRUITING
Osnabrück
ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
NOT_YET_RECRUITING
Pohlheim
Hegau-Bodensee-Klinikum Singen
NOT_YET_RECRUITING
Singen
Dr. Schmidt-Reinwald Astrid, Trier
NOT_YET_RECRUITING
Trier
Italy
A.O.U. Consorziale Policlinico di Bari
NOT_YET_RECRUITING
Bari
Policlinico Mater Domini Università di Catanzaro
NOT_YET_RECRUITING
Catanzaro
Università degli studi G. D'Annunzio Chieti Pescara - CAST
NOT_YET_RECRUITING
Chieti Scalo
AST Fermo - Ospedale Murri - Unità Operativa di Diabetologia e Endocrinologia
NOT_YET_RECRUITING
Fermo
Azienda Ospedaliero Universitaria Careggi - Diabetologia e malattie del metabolismo
NOT_YET_RECRUITING
Florence
DAI Scienze Mediche - UOC Endocrinologia
NOT_YET_RECRUITING
Messina
Azienda Ospedaliera Luigi Sacco
NOT_YET_RECRUITING
Milan
AOU Vanvitelli - DAI Medicina Interna, Geriatria e Neurologia - U.O.C. Endocrinologia e Malattie del Metabolismo
NOT_YET_RECRUITING
Napoli
Presidio Villa Belmonte
NOT_YET_RECRUITING
Palermo
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
NOT_YET_RECRUITING
Perugia
AUSL Romagna - Medicine Specialistiche Ravenna - UO Servizio di Diabetologia di Ravenna
NOT_YET_RECRUITING
Ravenna
Azienda Ospealiero Universitaria Policlinico Umberto I
NOT_YET_RECRUITING
Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Centro malattie endocrine e metaboliche
NOT_YET_RECRUITING
Rome
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 586
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov