| Outcome Measures: |
Primary: Change in Glycated Haemoglobin (HbA1c), Percent (%) point Baseline is defined as the time of Xultophy® initiation (V0); if the endpoint variable is unavailable at (V0), the most recent value within 3 months prior to Xultophy® initiation will be used. (This definition of baseline applies to all outcome measures.), From baseline (V0, month 0) to 6 months after initiation. | Secondary: Change in HbA1c, From baseline (V0, month 0) to end of study (V3, 18 ±3 months)|HbA1c levels less than 7% (yes/no), Percentage of patients - yes, At end of study (V3, 18 ±3 months)|HbA1c levels less than 7% without hypoglycaemic episodes (yes/no), Percentage of patients - yes, At end of study (V3, 18 ±3 months)|Reason for switching to Xultophy® (precoded question list), Percentage of patients, At baseline (V0, month 0)|Change in Xultophy® daily dose, Dose steps/day, From baseline (V0, month 0) to end of study (V3, 18 ±3 months)|Number of self-reported non-severe hypoglycaemia episodes (defined as an episode with symptoms and/or self monitored blood glucose (SMBG) value less than or equal to 3.9 mmol/L) based on recollection, Number of episodes, Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit|Number of self-reported nocturnal nonsevere hypoglycaemic episodes (defined based on the patient's perception of whether or not it was night) based on recollection, Number of episodes, Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit|Number of self-reported severe hypoglycaemic episodes (Defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action) based on recollection, Number of episodes, Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit|Treatment intensification (addition of prandial insulin, increase in total insulin dose or number of concomitant oral antidiabetics (OADs)) (yes/no), Percentage of patients with treatment intensification, At end of study (V3, 18 ±3 months)|Treatment simplification (decrease in insulin dose or number of concomitant OADs) (yes/no), Percentage of patients with treatment simplification, At end of study (V3, 18 ±3 months)
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| Locations: |
Ospedale Santa Maria Goretti - UOD Diabetologia, Latina, LT, 04100, Italy|ICS Maugeri, Pavia, Pv, 27100, Italy|A.O. SS Antonio e Biagio e Cesare Arrigo, Alessandria, 15121, Italy|INRCA, Ancona, 60127, Italy|Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato, Arezzo, 52100, Italy|Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, 24127, Italy|ASST OSpedali Civili ad indirizzo Metabolico Diabetologico, Brescia, 25123, Italy|Centro Polispecialistico Asl Toscana Nord Ovest, Carrara, 54033, Italy|D.S. 43 Casoria Asl Napoli 2 Nord, Casoria, 80026, Italy|H Cannizzaro Malattie endocrine e del ricambio e nutrizione, Catania, 95126, Italy|Ospedale S. Maria del Prato, Feltre, 32032, Italy|A.O.U. Ospedali Riuniti, Foggia, 71122, Italy|Ospedale Camberlingo, Francavilla Fontana, 72021, Italy|Ospedale Policlinico San Martino, Genova, 16132, Italy|A.O.U. Policlinico Martino, Messina, 98124, Italy|ASL Napoli 3 sud, Napoli, 80059, Italy|PSP Loreto Crispi, Napoli, 80122, Italy|Ospedale San Francesco d'Assisi, Oliveto Citra, 84020, Italy|Azienda Ospedaliera Padova, Padova, 35128, Italy|AUSL Pescara, Pescara, 65023, Italy|Ospedale San Jacopo, Pistoia, 51100, Italy|P.O. Praia a Mare ASP Cosenza, Praia a Mare, 87028, Italy|Policlinico Umberto I Clinica Medica DH Diabetologia, Roma, 00161, Italy|Casa della Salute Antistio, Roma, 00174, Italy|Policlinico Universitario AGemelli DH Patologie dell'Obesità, Rome, 00168, Italy|A.O.U. San Giovanni di Dio e Ruggi d'Aragona, Salerno, 84131, Italy|Ospedale San Donà di Piave, San Donà di Piave, 30027, Italy|ASUFC Udine, Udine, 33100, Italy
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