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
Key facts
- Where
- Bari, Catanzaro, Chieti Scalo, Fermo, Florence, Messina, Milan, Naples, Palermo, Perugia, Ravenna, and Rome, ItalySee the 13 sites
- Phase
- Phase 4
Where in Italy
- University Of Bari Aldo MoroBari, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria Renato DulbeccoCatanzaro, ItalyNot yet recruiting
- Universita' Degli Studi G. D'Annunzio Di ChietiChieti Scalo, ItalyNot yet recruiting
- Azienda Sanitaria Territoriale Di FermoFermo, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessina, ItalyNot yet recruiting
- ASST Fatebenefratelli SaccoMilan, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyNot yet recruiting
- Hospital Santa Maria Della MisericordiaPerugia, ItalyNot yet recruiting
- Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT07112339EU 2024-520068-32-00
- Record updated
- 11 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; Known or suspected hypersensitivity to study intervention(s) or related products; Any disorder which in the investigator's opinion might jeopardize participant's safety; Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method.