| Outcome Measures: |
Primary: Change in glycated haemoglobin (HbA1c), Measured as percentage (%)-points., From baseline (week 0) to end of treatment (week 40) | Secondary: Relative change in body weight, Measured in %., From baseline (week 0) to end of treatment (week 40)|Number of participants who achieve greater than or equal to (>=) 10% body weight reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 40)|Number of participants who achieve >=15% body weight reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 40)|Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol]), Measured as count of participants., At end of treatment (week 40)|Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol), Measured as count of participants., At end of treatment (week 40)|Change in Fasting Plasma Glucose (FPG), Measured in millimoles per liter (mmol/L)., From baseline (week 0) to end of treatment (week 40)|Number of participants who achieve >=5% body weight reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 40)|Number of participants who achieve >=20% body weight reduction, Measured as count of participants., From baseline (week 0) to end of treatment (week 40)|Change in waist circumference, Measured in centimeters (cm)., From baseline (week 0) to end of treatment (week 40)|Change in systolic blood pressure (SBP), Measured in millimeters of mercury (mmHg)., From baseline (week 0) to end of treatment (week 40)|Change in diastolic blood pressure (DBP), Measured in mmHg., From baseline (week 0) to end of treatment (week 40)|Ratio to baseline in high sensitivity C-reactive protein (hsCRP), Measured as ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to baseline in lipids: Total cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to baseline in lipids: Triglycerides, Measured as ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to baseline in lipids: Free fatty acids, Measured as ratio., From baseline (week 0) to end of treatment (week 40)|Ratio to baseline in lipids: Non-HDL cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 40)|Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication), Measured as count of participants., At end of study (week 52)|Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo), Measured as ratio., From baseline (week 0) to end of treatment (week 40)|Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score, Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The vitality score range is from 25.6 to 69.1., From baseline (week 0) to end of treatment (week 40)|Change in SF-36v2 score: Physical Component Summary score, Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for physical component summary is 6.1 to 79.7., From baseline (week 0) to end of treatment (week 40)|Change in SF-36v2 score: Mental Component Summary score, Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for mental component summary score is -3.8 to 78.7., From baseline (week 0) to end of treatment (week 40)|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score, Measured as score points. DTSQs measures treatment satisfaction and diabetes-specific quality of life. The measure consists of 8 items yielding 1 global score and 2 single item scores. Higher scores on the global score indicate greater satisfaction with treatment. Lower scores on the single-item scores indicate BG levels closer to the ideal, while higher scores indicate problems. Single-item scores (score range): Perceived frequency of hyperglycaemia (0-6), Perceived frequency of hypoglycaemia (0-6). Global score (score range): Total Treatment Satisfaction (0-36)., From baseline (week 0) to end of treatment (week 40)|Change in leptin, Measured in nanograms per milliliter (ng/mL)., From baseline (week 0) to end of treatment (week 40)|Change in soluble leptin receptor, Measured in ng/mL., From baseline (week 0) to end of treatment (week 40)|Number of Treatment Emergent Adverse Events (TEAEs), Measured as count of events., From baseline (week 0) to end of treatment +7 weeks (week 47)|Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter, Measured as count of episodes., From baseline (week 0) to end of treatment +7 weeks (week 47)|Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold, Measured as count of episodes., From baseline (week 0) to end of treatment + 7 weeks (week 47)
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| Locations: |
National Research Institute_Huntington Park, Huntington Park, California, 90255, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Southern California Dermatology, Santa Ana, California, 92701, United States|Encore Medical Research LLC, Hollywood, Florida, 33024, United States|Headlands Research Orlando, Orlando, Florida, 32819, United States|Encore Medical Research of Weston, Weston, Florida, 33331, United States|Alliance for Multispec Res, Newton, Kansas, 67114, United States|Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States|Arcturus Healthcare, PLC, Troy, Michigan, 48098, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|Summit Research Network Oregon Inc., Portland, Oregon, 97210, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Amarillo Medical Specialists, Amarillo, Texas, 79106, United States|Elligo Clin Res Centre, Austin, Texas, 78704, United States|Headlands Research Brownsville, Brownsville, Texas, 78526, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|Northeast Clinical Research of San Antonio, San Antonio, Texas, 78233, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Sugar Lakes Family Practice PA, Sugar Land, Texas, 77479, United States|Valley Diab. & Endo Comp Ctr, Weslaco, Texas, 78596, United States|TPMG Clinical Research, Newport News, Virginia, 23606, United States|Chinese People's Liberation Army General Hospital-Endocrinology, Beijing, Beijing, 100853, China|The Second Affiliated Hospital of Nanjing Medical University-Endocrinology, Nanjing, Jiangsu, 210011, China|The Affiliated Hospital of Jiangsu University-Endocrinology, Zhenjiang, Jiangsu, 212001, China|Jinan Central Hospital, Ji'Nan, Shandong, 250000, China|Belinus Bt., Debrecen, Hajdu-Bihar Varmegye, 4025, Hungary|Borbánya Praxis E.Ü. Kft., Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405, Hungary|Szent Margit Rendelőintézet Nonprofit Kft., Budapest, 1032, Hungary|PVN Kutato Kft., Budapest, 1102, Hungary|Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, 24127, Italy|Policlinico Mater Domini Università di Catanzaro, Catanzaro, 88100, Italy|IRCCS Ospedale San Raffaele Milano, Milano, 20132, Italy|Azienda Ospealiero Universitaria Policlinico Umberto I, Roma, 00161, Italy|Centrum Medyczne Medyk Sp. z o.o., Rzeszow, Podkarpackie, 35-055, Poland|Osteo-Medic s.c. A. Racewicz, J. Supronik, Bialystok, 15-351, Poland|Renew Clinic Sp. z o.o., Białystok, 15-797, Poland|Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A., Lodz, 90-338, Poland|NBR Polska Tomasz Klodawski, Warszawa, 00-710, Poland|Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji, Warszawa, 02-507, Poland|Velocity Nova Sp. z o.o., Zamość, 22-400, Poland|King Abdulaziz Hospital-Al Ahsa-National Guard, Al Ahsa, 36428, Saudi Arabia|National Guard Hospital - Jeddah, Jeddah, 21423, Saudi Arabia|King Fahad Medical City, Riyadh, 11525, Saudi Arabia|King Khaled University Hospital,King Saud Univ. Med. City, Riyadh, 12372, Saudi Arabia|King Salman Bin Abdulaziz Hospital, Riyadh, 12769, Saudi Arabia|CHC Zvezdara, Clinical department for endocrinology, Belgrade, 11000, Serbia|Clinical Hospital Center Bezanijska Kosa, Belgrade, 11080, Serbia|Clinical Hospital Centre Zemun, Belgrade, 11080, Serbia|Policlinic for diabetes, Zajecar, 19000, Serbia
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