| Outcome Measures: |
Primary: Absolute change in glycated haemoglobin (HbA1c) (percentage [%]-point), Measured in %-point., From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)|Absolute change in glycated haemoglobin (HbA1c) (millimoles per mole [mmol/mol]), Measured in mmol/mol., From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks) | Secondary: Relative change in body weight, Measured in percentage (%)., From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)|Absolute change in body weight, Measured in Kilograms (kg)., From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)|Absolute change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides), Measured in millimoles per liter (mmol/L)., From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)|Absolute change in waist circumference, Measured in centimeters (cm)., From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)|Absolute change in blood pressure (systolic and diastolic), Measured in millimeters of mercury (mmHg)., From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)|Number of participants with HbA1c less than (<) 7%, Measured as number of participants (yes or no)., At end of study (week 40 ± 4 weeks)|Number of participants with HbA1c <6.5%, Measured as number of participants (yes or no)., At end of study (week 40 ± 4 weeks)|HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 5%, Measured as number of participants (yes or no)., From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)|HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 3%, Measured as number of participants (yes or no)., From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)|Self-reported severe hypoglycaemia during the study period, Measured as number of participants (yes or no)., From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)|Absolute change in dutch eating behaviour questionnaire (DEBQ) scores (points), DEBQ is a 33-item self-reported questionnaire to assess three distinct eating behaviours in adults: emotional eating, external eating, and restrained eating. For all 33 items participants will provide response in terms of: never, seldom, sometimes, often, very often. Absolute change in DEBQ (total score) calculated as the absolute difference between the DEBQ scores (total score) at baseline and post baseline measurements of DEBQ scores (total score) up to and including end of study visit., From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)|Absolute change in diabetes distress survey (DDS) scores (points), DDS is a self-administered 17-item scale that captures four critical dimensions of diabetes-related distress: emotional burden, regimen distress, interpersonal distress, and physician distress. Each item was scored in the range of 1 to 6: 1) not a problem; 2) a slight problem; 3) a moderate problem; 4) somewhat serious problem; 5) a serious problem; 6) a very serious problem. Participants will rate each item item indicating the degree to which each of the 17 items may have distressed or bothered them during the past month. High score indicated high distress., From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
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| Locations: |
Ospedale Pesenti Fenaroli, Alzano Lombardo, 24022, Italy|INRCA, Ancona, 60127, Italy|A.O.U. Policlinico S.Orsola, Bologna, 40138, Italy|Ospedale centrale L. Bohler, Bolzano, 39100, Italy|ASL Caserta, Caserta, 81100, Italy|Azienda Ospedaliera Cannizzaro, Catania, 95126, Italy|ASL Cuneo 1, Cuneo, 12100, Italy|Università degli Studi Foggia, Foggia, 71122, Italy|Ospedale Misericordia, Grosseto, 58100, Italy|Ospedale Generale provinciale, Macerata, 62100, Italy|Ospedale Pagliari, Massafra, 74016, Italy|ASL Avellino, Montoro, 83026, Italy|ASL Lecce, Nardò, 73048, Italy|ASL Napoli 3 sud, Palma Campania, 80036, Italy|A.O.U. Maggiore della Carità, Piemonte, 28100, Italy|Ospedale San Jacopo, Pistoia, 51100, Italy|P.O. Praia a Mare, Praia a Mare, 87028, Italy|Casa della Salute ASL RM2, Roma, 00159, Italy|Fondazione Univ. Policlinico A.Gemelli, Roma, 00168, Italy|Ospedale Santo Spirito, Roma, 00195, Italy|A.O.U. Policlinico Giaccone, Sicilia, 90127, Italy|Casa di cure Triolo Zancla, Sicilia, 90133, Italy|Ospedale Treviglio, Treviglio, 24047, Italy|Ospedale S. Maria della Misericordia, Udine, 33100, Italy|ASST Sette Laghi, Varese, 21100, Italy
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