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
- Diseases
- Type 2 diabetes
- 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
Sites (75)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centricity Research Brampton Endocrinology Coordinator of this site? Confirm its status | Brampton | Canada | Recruiting |
| Centricity Clinical Research Burlington Coordinator of this site? Confirm its status | Burlington | Canada | Completed |
| Centricity Research Calgary Endocrinology Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| Centricity Research Vaughn Endocrinology Coordinator of this site? Confirm its status | Concord | Canada | Recruiting |
| Medical Trust Clinics, Inc. Coordinator of this site? Confirm its status | Courtice | Canada | Completed |
| Alta Clinical Research at Hermitage Medicentre Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Centricity Research Etobicoke Endocrinology Coordinator of this site? Confirm its status | Etobicoke | Canada | Recruiting |
| Janik Research Coordinator of this site? Confirm its status | Greater Sudbury | Canada | Recruiting |
| Hamilton Medical Research Group Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Diex Recherche (Joliette) Coordinator of this site? Confirm its status | Joliette | Canada | Recruiting |
| Alpha Recherche Clinique - Clinique de Levis Coordinator of this site? Confirm its status | Lévis | Canada | Recruiting |
| Western Univ. Cnt for Studies in Fam Med Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| St. Josephs Health Care Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Centricity Research Mirabel Coordinator of this site? Confirm its status | Mirabel | Canada | Recruiting |
| Malton Medical Clinic Coordinator of this site? Confirm its status | Mississauga | Canada | Completed |
| G.A. Research Associates, Ltd. Coordinator of this site? Confirm its status | Moncton | Canada | Recruiting |
| Clinique Endocrinologie OASIS. Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| Applied Medical Informatics Research Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| Centricity Research Ottawa LMC Coordinator of this site? Confirm its status | Nepean | Canada | Recruiting |
| Fraser Clinical Trials, Inc. Coordinator of this site? Confirm its status | New Westminster | Canada | Recruiting |
| The Ottawa Hospital_Riverside Coordinator of this site? Confirm its status | Ottawa | Canada | Not yet recruiting |
| Centricity Res Pointe-Claire Coordinator of this site? Confirm its status | Pointe-Claire | Canada | Recruiting |
| Centre de Recherche Saint-Louis Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Alpha Recherche Clinique - Lebourgneuf Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Recherche Clinique Sigma inc Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Diex Recherche Québec Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Alpha Recherche Clinique Coordinator of this site? Confirm its status | Québec | Canada | Completed |
| Bluewater Clin Res Group Inc Coordinator of this site? Confirm its status | Sarnia | Canada | Completed |
| Centre de Recherche Saint-Louis Coordinator of this site? Confirm its status | Sherbrooke | Canada | Recruiting |
| Diex Recherche Sherbrooke Coordinator of this site? Confirm its status | Sherbrooke | Canada | Completed |
| Ctr de Med Metab de Lanaudiere Coordinator of this site? Confirm its status | Terrebonne | Canada | Recruiting |
| Centricity Research Toronto Manna Multispec Coordinator of this site? Confirm its status | Toronto | Canada | Completed |
| Centricity Research Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Sewa Ram Singal Medicine Professional Corp Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Diex Recherche Trois-Rivieres Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Recruiting |
| Diex Recherche Victoriaville Coordinator of this site? Confirm its status | Victoriaville | Canada | Recruiting |
| Winnipeg Clinic Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
| Versdias GmbH Coordinator of this site? Confirm its status | Amberg | Germany | Not yet recruiting |
| MVZ DiaMedicum Bad Mergentheim GmbH Coordinator of this site? Confirm its status | Bad Mergentheim | Germany | Not yet recruiting |
| Praxis Dr. Stephan Scharla Coordinator of this site? Confirm its status | Bad Reichenhall | Germany | Not yet recruiting |
| Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Studiengesellschaft Drs Könemann / Steinmann Coordinator of this site? Confirm its status | Bünde | Germany | Not yet recruiting |
| Diabetologische Schwerpunktpraxis Daaden Coordinator of this site? Confirm its status | Daaden | Germany | Not yet recruiting |
| Diabeteszentrum-Do Dres. K U. Ch. Busch GbR Coordinator of this site? Confirm its status | Dortmund | Germany | Not yet recruiting |
| Studienzentrum Dr. Faulmann GbR Coordinator of this site? Confirm its status | Dresden | Germany | Not yet recruiting |
| MVZ Hausärzte Großenbaum GmbH Coordinator of this site? Confirm its status | Duisburg | Germany | Not yet recruiting |
| Praxis für Diabetologie, Angiologie und Innere Medizin Eisenach Coordinator of this site? Confirm its status | Eisenach | Germany | Not yet recruiting |
| Praxis am Markt Dr. Becker Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| MVZ Contilia GmbH - Studienzentrum Diabetologie Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| MVZ im Altstadt-Carree Fulda GmbH Coordinator of this site? Confirm its status | Fulda | Germany | Not yet recruiting |
| Diabetes Zentrum Wilhelmsburg GbR Coordinator of this site? Confirm its status | Hamburg | Germany | Not yet recruiting |
| Mesut Durmaz Schwerpunktpraxis für Diabetes, Hormone & Stoffwechsel Studienzentrum Coordinator of this site? Confirm its status | Hof | Germany | Not yet recruiting |
| Praxisgemeinschaft Jerichow Schulze Coordinator of this site? Confirm its status | Jerichow | Germany | Not yet recruiting |
| Familienmedizinisches Zentrum Radowsky Coordinator of this site? Confirm its status | Leipzig | Germany | Not yet recruiting |
| Praxis Am Oberen Tor Coordinator of this site? Confirm its status | Lichtenfels | Germany | Not yet recruiting |
| Diabeteszentrum Ludwigsburg Coordinator of this site? Confirm its status | Ludwigsburg | Germany | Not yet recruiting |
| Institut für Diabetesforschung Osnabrück Coordinator of this site? Confirm its status | Osnabrück | Germany | Not yet recruiting |
| Centrum Fuer Diabetologie Und Allgemeinmedizin Coordinator of this site? Confirm its status | Pohlheim | Germany | Not yet recruiting |
| Gesundheitsverbund Landkreis Konstanz gGmbH Coordinator of this site? Confirm its status | Singen (Hohentwiel) | Germany | Not yet recruiting |
| Praxis Dr. Astrid Schmidt-Reinwald Coordinator of this site? Confirm its status | Trier | Germany | Not yet recruiting |
| University Of Bari Aldo Moro Coordinator of this site? Confirm its status | Bari | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Renato Dulbecco Coordinator of this site? Confirm its status | Catanzaro | Italy | Not yet recruiting |
| Universita' Degli Studi G. D'Annunzio Di Chieti Coordinator of this site? Confirm its status | Chieti Scalo | Italy | Not yet recruiting |
| Azienda Sanitaria Territoriale Di Fermo Coordinator of this site? Confirm its status | Fermo | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Gaetano Martino Messina Coordinator of this site? Confirm its status | Messina | Italy | Not yet recruiting |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Not yet recruiting |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Not yet recruiting |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.