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Clinical Trial Details

Trial ID: L4358
Source ID: NCT06113341
Associated Drug: Ideglira
Title: A Research Study in Italy to Understand How the Dose Check App Used With Xultophy® Works in the Treatment of People Living With Type 2 Diabetes
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: IDegLira
Outcome Measures: Primary: Participant downloaded and actively used the app (Yes/No), Measured as count of participants., From baseline (week 0) to end of the study (EOS) visit (week 26) | Secondary: Change in glycated haemoglobin (HbA1c), Measured as percentage (%) points., From baseline (week 0) to EOS visit (week 26)|Participants reaching individual HbA1c target set by physician, Measured as count of participants (yes/no)., At EOS visit (week 26)|Participants reaching physician set individual fasting blood glucose (FBG) target, Measured as count of participants (yes/no)., From baseline (week 0) to EOS visit (week 26)|Time to physician set individual FBG target from first reported FBG, Measured in number of weeks., From baseline (week 0) to EOS visit (week 26)|Participants achieving target level FBG according to clinical guidance, Measured as count of participants (yes/no)., From baseline (week 0) to EOS visit (week 26)|Change in laboratory measured FPG, Measured in milligrams per deciliter (mg/dL)., From baseline (week 0) to EOS visit (week 26)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 0
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2024-11-07
Completion Date: 2026-03-02
Results First Posted:
Last Update Posted: 2024-10-01
Locations: Azienda Ospedaliero-Universitaria Renato Dulbecco, Catanzaro, Cz, 88100, Italy|Azienda Ospedaliero Universitario Policlinico "G. Martino", Gazi, ME, 98124, Italy|Azienda Ospedaliera Cannizzaro, Catania, Sicily, 95126, Italy|A.O. SS Antonio e Biagio e Cesare Arrigo, Alessandria, 15121, Italy|Azienda Ospedaliera Ospedale Policlinico Consorziale, Bari, 70120, Italy|Azienda Ospedaliero-Universitaria Renato Dulbecco, Catanzaro, 88100, Italy|Ospedale di Chivasso, Chivasso, 10034, Italy|Presidio Ospedale di Cittadella Azienda ULSS 6 Euganea, Cittadella, 35013, Italy|Ospedale Santa Croce, Fano, 61032, Italy|Presidio Ospedaliero Santa Barbara, Iglesias, 09016, Italy|IRCCS Ospedale Sacro Cuore Don Calabria, Negrar Di Valpolicella, 37024, Italy|Ospedale San Francesco d'Assisi, Oliveto Citra, 84020, Italy|ARNAS Ospedali Civico Di Cristina Benfratelli, Palermo, 90127, Italy|Azienda Ospedaliero Universitaria Pisana Ospedale Cisanello, Pisa, 56124, Italy|Nuovo Ospedale degli Infermi, Ponderano, 13875, Italy|DIABETOLOGIA Ravenna AUSL della Romagna, Ravenna, 48121, Italy|AUSL Reggio Emilia, Reggio Emilia, 42123, Italy|A.O.U. Policlinico Umberto I, Roma, 00161, Italy|Fondazione Univ. Policlinico A.Gemelli, Roma, 00168, Italy
URL: https://clinicaltrials.gov/show/NCT06113341