| Outcome Measures: |
Primary: Change in glycated haemoglobin (HbA1c), Measured in Percentage (%)-points., From randomisation (week 0) to week 52 | Secondary: Change in body weight, Measured in kilograms (kg)., From randomisation (week 0) to week 52|Change in fasting plasma glucose (FPG), Measured in millimoles per liter (mmol/L)., From randomisation (week 0) to week 52|Change in 7 point self measured plasma glucose (SMPG) mean profile, Measured in mmol/L., From randomisation (week 0) to week 52|Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments, Measured in mmol/L., From randomisation (week 0) to week 52|Relative change in body weight, Measured in Percentage (%)., From randomisation (week 0) to week 52|Change in waist circumference, Measured in centimeters (cm)., From randomisation (week 0) to week 52|HbA1c less than or equal to (≤) 6.5% (Yes/No), Measured as count of participants., At week 52|HbA1c less than (<) 7% (Yes/No), Measured as count of participants., At week 52|Body weight reduction greater than equal to ( ≥) 5% (Yes/No), Measured as count of participants., At week 52|Body weight reduction ≥10% (Yes/No), Measured as count of participants., At week 52|Body weight reduction ≥15% (Yes/No), Measured as count of participants., At week 52|HbA1c <7.0% and body weight reduction ≥5% (Yes/No), Measured as count of participants., At week 52|Change in systolic blood pressure, Measured in millimeters of mercury (mmHg)., From randomisation (week 0) to week 52|Change in diastolic blood pressure, Measured in mmHg., From randomisation (week 0) to week 52|Change in High-sensitivity C-reactive protein (hsCRP), Measured in milligrams per liter (mg/L)., From randomisation (week 0) to week 52|Time to rescue medication, Measured in days., From randomisation (week 0) to week 104|Change in HbA1c, Measured in %-points., From randomisation (week 0) to week 104|Change in body weight, Measured in kg., From randomisation (week 0) to week 104|Change in FPG, Measured in mmol/L., From randomisation (week 0) to week 104|Change in 7 point SMPG mean profile, Measured in mmol/L., From randomisation (week 0) to week 104|Change in 7-point SMPG mean post prandial increments, Measured in mmol/L, From randomisation (week 0) to week 104|Relative change in body weight, Measured in Percentage., From randomisation (week 0) to week 104|Change in waist circumference, Measured in cm., From randomisation (week 0) to week 104|HbA1c ≤6.5% (Yes/No), Measured as count of participants., At week 104|HbA1c <7.0% (Yes/No), Measured as count of participants., At week 104|Body weight reduction ≥5% (Yes/No), Measured as count of participants., At week 104|Body weight reduction ≥10% (Yes/No), Measured as count of participants., At week 104|Body weight reduction ≥15% (Yes/No), Measured as count of participants., At week 104|HbA1c <7.0% and body weight reduction ≥5% (Yes/No), Measured as count of participants., At week 104|Change in systolic blood pressure, Measured in mmHg., From randomisation (week 0) to week 104|Change in diastolic blood pressure, Measured in mmHg., From randomisation (week 0) to week 104|Change in hsCRP, Measured in mg/L., From randomisation (week 0) to week 104|Treatment emergent adverse events, Measured as count of events., From randomisation (week 0) to week 52|Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes, Measured as count of episodes., From randomisation (week 0) to week 52|Treatment emergent adverse events, Measured as count of events., From randomisation (week 0) to follow-up visit (week 109)|Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes, Measured as count of episodes., From randomisation (week 0) to follow-up visit (week 109)|Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain, CoEQ is a 19-item multidimensional patient reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control., From randomisation (week 0) to week 52|Change in CoEQ score - Craving for Savory domain, CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving savoury food subscale, higher score represents a greater level of craving., From randomisation (week 0) to week 52|Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) score - Physical function domain, IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0 100), Physical Function composite (0-100). Total score range (0-100)., From randomisation (week 0) to week 52|Change in American Heart Association (AHA) Life's Simple 7 summary score, The AHA recommends focusing on 7 cardiovascular health factors (smoking, BMI, physical activity, diet, total cholesterol, blood pressure, and fasting blood glucose) for early or primary prevention of cardiovascular disease. The 7 health factors are each categorized as ideal, intermediate, or poor. Scales range from 0 (minimum) to 14 (maximum). Higher score represents a greater level of health., From randomisation (week 0) to week 52|Change in CoEQ score - Craving Control domain, CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control., From randomisation (week 0) to week 104|Change in CoEQ score - Craving for Savory domain, CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving savoury food subscale, higher score represents a greater level of craving., From randomisation (week 0) to week 104|Change in IWQOL-Lite-CT score - Physical function domain, IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0 100), Physical Function composite (0-100). Total score range (0-100)., From randomisation (week 0) to week 104|Change in AHA Life's Simple 7 summary score, The AHA recommends focusing on 7 cardiovascular health factors (smoking, BMI, physical activity, diet, total cholesterol, blood pressure, and fasting blood glucose) for early or primary prevention of cardiovascular disease. The 7 health factors are each categorized as ideal, intermediate, or poor. Scales range from 0 (minimum) to 14 (maximum). Higher score represents a greater level of health., From randomisation (week 0) to week 104
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| Locations: |
Hillcrest Family Health Center, Waco, Texas, 76708, United States|Instituto de Ciências Farmacêuticas, Goiânia, Goias, 74935-330, Brazil|Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda., Porto Alegre, Rio Grande Do Sul, 90430-001, Brazil|CPQuali Pesquisa Clínica Ltda, São Paulo, Sao Paulo, 01228-000, Brazil|CPCLIN - Centro de Pesquisas Clínicas, São Paulo, Sao Paulo, 01228-200, Brazil|Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd., Kyustendil, 2500, Bulgaria|Diagnostic-Consultative Centre "Sveti Georgi" Eood, Plovdiv, 4002, Bulgaria|"Aipsomcemd - Dr. Petya Georgieva" Eood, Plovdiv, 4018, Bulgaria|''Aipsomcidemd - Dr. Lilyana Bodurova-Troharova" Eood, Samokov, 1000, Bulgaria|"Medical center Medishtit Velisia" OOD, Stara Zagora, 6000, Bulgaria|Diagnostic Consulting Center 1 Velingrad EOOD, Velingrad, 4600, Bulgaria|MHAT- Hristo Botev AD, Vratsa, 3000, Bulgaria|Poliklinika SLAVONIJA OSIJEK, Osijek, Osječko - Baranjska Županija, 31000, Croatia|Opca bolnica Karlovac, Karlovac, 47000, Croatia|Specijalna bolnica Krapinske Toplice - Endokrinologija, Krapinske Toplice, 49217, Croatia|Opca bolnica Pula, Pula, 52100, Croatia|Specijalna bolnica Medico, Rijeka, 51000, Croatia|Iatriko Psychicou Private Clinic, Athens, 115 25, Greece|"Laiko" General Hospital of Athens, Athens, GR-11527, Greece|Iatriko Athinon (Athens Medical Canter), Athens, GR-15125, Greece|Iatriko Athinon 'Palaiou Falirou', Athens, GR-17562, Greece|University Hospital of Athens ATTIKON, Haidari-Athens, GR-12462, Greece|University General Hospital of Ioannina,Internal Medicine, Ioannina, 45500, Greece|General Hospital of Thessaloniki 'G. Gennimatas, Thessaloniki, GR-54635, Greece|EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes, Thessaloniki, GR-54643, Greece|"Thermi" Private Hosital, Thessaloniki, GR-57001, Greece|General Hospital of Thessaloniki "G.Papanikolaou", Thessaloniki, GR-57010, Greece|ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest, 1089, Hungary|Belinus Bt., Debrecen, 4025, Hungary|Osmania General Hospital, Hyderabad, A.p., 500 063, India|Endolife Specialty Hospitals, Guntur, Andhra Pradesh, 522001, India|Yalamanchi Hospitals and Research centres pvt ltd, Vijaywada, Andhra Pradesh, 520002, India|Navneeth Memorial Hospital, Ahmedabad, Gujrat, 380009, India|Govt Medical College, Vadodara, Gujrat, 390001, India|Ramaiah Memorial Hospital, Bangalore, Karnataka, 560054, India|Lifecare Hospital and Research Centre, Bangalore, Karnataka, 560092, India|K R Hospital, Mysuru, Karnataka, 570001, India|TOTALL Diabetes Hormone Institute, Indore, Madhya Pradesh, 452010, India|Goa Medical College, Goa, Maharashtra, 403 202, India|Excel Endocrine Centre, Kolhapur, Maharashtra, 416008, India|Seth GS Medical College & KEM Hospital, Mumbai, Maharashtra, 400012, India|BSES MG hospital, Mumbai, Maharashtra, 400058, India|Ashirwad Hospital and Research Centre, Thane, Maharashtra, 421004, India|Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha, Wardha, Maharashtra, 442001, India|Maulana Azad Medical College, Delhi, New Delhi, 110002, India|Dayanand Medical College & Hospital_Ludhiana, Ludhiana, Punjab, 141001, India|Jawahar Lal Nehru Govt. Medical College, Ajmer, Rajasthan, 305001, India|Diabetes, Thyroid and Endocrine Centre, Jaipur, Rajasthan, 302006, India|M.V.Hospital for Diabetes Pvt. Ltd., Chennai, Tamil Nadu, 600 013, India|Gandhi Hospital & Medical college, Hyderabad, Telengana, 500003, India|Yashoda hospital, Hyderabad, Telengana, 500082, India|Medanta Lucknow Hospital, Lucknow, Uttar Pradesh, 226030, India|BP Poddar Hospital, Kolkata,, West Bengal, 700053, India|Swasthya Diabetes Care, Ahmedabad, 390013, India|Aligarh Muslim University, Aligarh, 202002, India|Sparsh Hospital, Bhubaneshwar, Bhubaneshwar, 751007, India|All India Institute of Medical Sciences (AIIMS), Nagpur, Maharashtra, 441108, India|JIPMER, Puducherry, 605006, India|Lifepoint Multispecialty Hospital, Pune, 411057, India|Mahatma Gandhi Memorial Hospital, Sherpura, Warangal, 506002, India|Hospital Miri, Sarawak, Miri, 98000, Malaysia|Klinik Kesihatan Kuang, Rawang, Selangor, 48050, Malaysia|Klinik Kesihatan Bintulu, Bintulu, 97000, Malaysia|Klinik Kesihatan Greentown Ipoh, Ipoh, 30450, Malaysia|Klinik Kesihatan Cheras Baru, Kuala Lumpur, 56100, Malaysia|Hospital Melaka, Melaka, 75400, Malaysia|Hospital Seri Manjung, Seri Manjung, 32040, Malaysia|Hospital Sultan Haji Ahmad Shah, Temerloh,Pahang, 28000, Malaysia|Medical Care and Research S. A de C.V, Merida, Yucatan, 97070, Mexico|Eme Red Hospitalaria, Mérida, Yucatán, 97070, Mexico|FAICIC S. de R.L. de C.V., Veracruz, 91900, Mexico|Clinmedica Research sp. z o.o., Skierniewice, Lodzkie, 96-100, Poland|ETG Siedlce, Siedlce, Masovian, 08-110, Poland|NZOZ Vita-Diabetica Malgorzata Buraczyk, Bialystok, Podlaskie Voivodeship, 15-879, Poland|Centrum Medyczne Intercor Sp. z o.o., Bydgoszcz, 85-605, Poland|Diab Serwis Popenda Spółka Jawna, Chorzów, 41-500, Poland|NZOZ Euromedica, Grudziadz, 86-300, Poland|Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A., Olsztyn, 10-117, Poland|ENDOPRACTICA W.Beker, D.Mielczarek, P.Mielczarek, J.Struzik spółka cywilna, Opole, 45-301, Poland|NZOZ NEURO-KARD Ilkowski i Partnerzy Spółka Partnerska Lekarzy, Poznań, 61-853, Poland|Centrum Medyczne Oporow, Wroclaw, 52-416, Poland|Centra Medyczne Medyceusz Sp. z o.o., Łódź, 91-053, Poland|Trialmed CRS, Piotrków Trybunalski, Łódzkie, 97-300, Poland|Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila, Bucharest, Bucurestii, 020475, Romania|Sc Mediab Srl, Targu Mures, Mures, 540142, Romania|Sc Mediab Srl, Tirgu Mures, Mures, 540142, Romania|Clinica Grivitei 224 S.R.L., Braila, 810197, Romania|SC Nutrilife SRL, Bucharest, 013764, Romania|Diabet Med SRL, Bucuresti, 050913, Romania|S.C. Dianutrilife Medica S.R.L., Ploiesti, 100561, Romania|Clinica Korall S.R.L. Satu Mare, Satu-Mare, 440055, Romania|Healthcare centre Zvezdara, Belgrade, RS, 11050, Serbia|Healthcare centre Kragujevac, Kragujevac, RS, 34000, Serbia|Healthcare centre Nis, Nis, RS, 18000, Serbia|Siriraj Hospital, Bangkok Noi, Bangkok, 10700, Thailand|Thammasat University Hospital, Klong Luang, Pathum Thani, 12120, Thailand|Rajavithi Hospital, Bangkok, 10400, Thailand|Ramathibodi Hospital, Bangkok, 10400, Thailand|Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, 50200, Thailand|Srinagarind Hospital, Khon Kaen, 40002, Thailand|Songklanagarind Hospital, Songkla, 90110, Thailand
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