| Outcome Measures: |
Primary: Change from Baseline in Hemoglobin A1c (HbA1c), Baseline, Week 104 | Secondary: Change from Baseline in HbA1c, Baseline, Week 208|Change from Baseline in Weight, Baseline, Week 104|Change from Baseline in Weight, Baseline, Week 208|Change from Baseline in Waist Circumference, Baseline, Week 104|Change from Baseline in Waist Circumference, Baseline, Week 208|Change from Baseline in Fasting Serum Glucose (FSG), Baseline, Week 104|Change from Baseline in FSG, Baseline, Week 208|Change from Baseline in Lipids, Baseline, Week 104|Change from Baseline in Lipids, Baseline, Week 208|Percentage of Participants Achieving HbA1c <7.0%, Week 104|Percentage of Participants Achieving HbA1c ≤6.5%, Week 104|Percentage of Participants Achieving HbA1c <5.7%, Week 104|Percentage of Participants Achieving HbA1c <7.0%, Week 208|Percentage of Participants Achieving HbA1c ≤6.5%, Week 208|Percentage of Participants Achieving HbA1c <5.7%, Week 208|Change from Baseline in Weight loss of ≥5%,, Baseline, Week 104|Change from Baseline in Weight loss of ≥10%, Baseline, Week 104|Change from Baseline in Weight loss of ≥15%, Baseline, Week 104|Change from Baseline in Weight loss of ≥5%, Baseline, Week 208|Change from Baseline in Weight loss of ≥10%, Baseline, Week 208|Change from Baseline in Weight loss of ≥15%, Baseline, Week 208|A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia, A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as blood glucose (BG) \<54 milligram/deciliter (mg/dL) \<3.0 millimole/liter (mmol/L) and/or severe hypoglycemia, Week 104|A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia, A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as BG \<54 mg/dL (\<3.0 mmol/L) and/or severe hypoglycemia, Week 208|Change from Baseline in β-cell Glucose Sensitivity, β-cell Glucose Sensitivity assessed by Oral Glucose Tolerance Test (OGTT), Baseline, Week 104|Change from Baseline in β-cell glucose sensitivity, Change from baseline in β-cell glucose sensitivity assessed by OGTT, Baseline, Week 208|Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration, Insulin Secretion Rate assessed by OGTT, Baseline, Week 104|Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration, Insulin Secretion Rate assessed by OGTT, Baseline, Week 208|Change from Baseline in Postprandial Insulin Sensitivity Indices, Postprandial Insulin Sensitivity Indices assessed by OGTT, Baseline, Week 104|Change from Baseline in Postprandial Insulin Sensitivity Indices, Postprandial Insulin Sensitivity Indices assessed by OGTT, Baseline, Week 208|Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)], Fasting and Post-challenge Glucose \[total and incremental AUC(₀-₂₄₀min)\] assessed by OGTT, Baseline through Week 104|Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)], Fasting and Post-challenge Glucose \[total and incremental AUC(₀-₂₄₀min)\] assessed by OGTT, Baseline through Week 208|Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Domain, Baseline, Week 104|Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain, Baseline, Week 208
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| Locations: |
Cahaba Research - Trussville, Birmingham, Alabama, 35235, United States|San Fernando Valley Health Institute, Canoga Park, California, 91304, United States|Velocity Clinical Research, Huntington Park, Huntington Park, California, 90255, United States|Velocity Clinical Research, San Diego, La Mesa, California, 91942, United States|Clinical Trials Research, Lincoln, California, 95648, United States|Velocity Clinical Research, Westlake, Los Angeles, California, 90057, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Velocity Clinical Research, North Hollywood, North Hollywood, California, 91606, United States|Velocity Clinical Research, Panorama City, Panorama City, California, 91402, United States|Western University of Health Sciences, Pomona, California, 91766, United States|Velocity Clinical Research, Santa Ana, Santa Ana, California, 92704, United States|New England Research Associates, LLC, Bridgeport, Connecticut, 06606, United States|Excel Medical Clinical Trials, Boca Raton, Florida, 33434, United States|Alliance for Multispecialty Research, LLC, Coral Gables, Florida, 33134, United States|South Florida Clinical Research Institute, Margate, Florida, 33063, United States|Emory University School of Medicine- Grady Campus, Atlanta, Georgia, 30303, United States|Center for Advanced Research & Education, Gainesville, Georgia, 30501, United States|Qualmedica Research, LLC, Evansville, Indiana, 47715, United States|Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States|Qualmedica Research, Bowling Green, Kentucky, 42101, United States|NECCR PrimaCare Research, Fall River, Massachusetts, 02721, United States|SKY Integrative Medical Center/SKYCRNG, Ridgeland, Mississippi, 39157, United States|StudyMetrix Research, Saint Peters, Missouri, 63303, United States|Clinvest Research LLC, Springfield, Missouri, 65807, United States|Research Foundation of SUNY - University of Buffalo, Buffalo, New York, 14221, United States|Lucas Research, Inc, Morehead City, North Carolina, 28557, United States|The Corvallis Clinic, P.C., Corvallis, Oregon, 97330, United States|Clinical Research of Philadelphia, Philadelphia, Pennsylvania, 19114, United States|Preferred Primary Care Physicians, Uniontown, Pennsylvania, 15401, United States|Tribe Clinical Research, LLC, Greenville, South Carolina, 29607, United States|Velocity Clinical Research, Spartanburg, Spartanburg, South Carolina, 29303, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056, Argentina|Instituto de Investigaciones Clínicas Mar del Plata, Mar del Plata, Buenos Aires, 7600, Argentina|Go Centro Medico San Nicolás, San Nicolas, Buenos Aires, 2900, Argentina|CIAD Moron, Moron, Buenos Air, B1708EPE, Argentina|Centro Médico Viamonte, Buenos Aires, Ciudad Aut, C1120AAC, Argentina|Dr. M.B. Jones Inc., Victoria, British Columbia, V8V 4A1, Canada|Bluewater Clinical Research Group Inc., Sarnia, Ontario, N7T 4X3, Canada|Stouffville Medical Centre, Stouffville, Ontario, L4A 1H2, Canada|9109-0126 Quebec Inc., Montreal, Quebec, H4N 2W2, Canada|ClinPhenomics CVC GmbH, Frankfurt, Hessen, 60596, Germany|Diabetes- und Stoffwechselpraxis Bochum, Bochum, Nordrhein-Westfalen, 44869, Germany|InnoDiab Forschung Gmbh, Essen, Nordrhein-Westfalen, 45136, Germany|Zentrum für klinische Studien, Saint Ingbert, Saarland, 66386, Germany|Arztpraxis Christine Kosch Pirna, Pirna, Sachsen, 01796, Germany|RED-Institut GmbH, Oldenburg, Schleswig-Holstein, 23758, Germany|Diabetespraxis Mergentheim, Bad Mergentheim, 97980, Germany|Diabetes Zentrum Dr. Tews, Gelnhausen, 63571, Germany|Clalit Health Services - Atlit, Atlit, HaDarom, Israel|Edith Wolfson Medical Center, Holon, HaMerkaz, 5810001, Israel|Rabin Medical Center, Petah-Tikva, HaMerkaz, 4941492, Israel|Sheba Medical Center, Ramat Gan, HaMerkaz, 5262100, Israel|Kaplan Medical Center, Rehovot, HaMerkaz, 7610001, Israel|Bnai Zion Medical Center, Haifa, HaTsafon, 3339419, Israel|Clalit Health Services - Sakhnin Community Clinic, Sakhnin, HaTsafon, 3081000, Israel|Hadassah Medical Center, Jerusalem, Yerushalayim, 9112001, Israel|Linn Medical Center, Haifa, Ḥeifā, 3515209, Israel|University of Naples Federico II, Napoli, Campania, 80131, Italy|Centro Cardiologico Monzino, Milan, Milano, 20138, Italy|Ospedale Civile Santa Croce Pronto Soccorso, Moncalieri, Piemonte, 10024, Italy|A.O.U.C. Policlinico di Bari, Bari, Puglia, 70124, Italy|Ospedale san Giovanni di Dio-Diabetologia, Olbia, Sardegna, 07026, Italy|A.O.U. Policlinico Paolo Giaccone, Palermo, Sicilia, 90129, Italy|Azienda Ospedaliera Universitaria Pisana, Pisa, Toscana, 56124, Italy|AOU Renato Dulbecco, Catanzaro, 88100, Italy|Private Practice - Dr. Arechavaleta Granell Maria del Rosario, Guadalajara, Jalisco, 44670, Mexico|Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo León, 66460, Mexico|Investigacion En Salud Y Metabolismo Sc, Chihuahua, 31217, Mexico|San Juan Bautista School of Medicine - Clinical Research Unit, Caguas, 00725, Puerto Rico|Dorado Medical Complex, Dorado, 00646, Puerto Rico|GCM Medical Group, PSC - Hato Rey Site, San Juan, 00917, Puerto Rico|Diabdana, Oradea, Bihor, 410147, Romania|C.M.D.T.A. Neomed, Brasov, Brașov, 500283, Romania|Centrul Medical NutriLife, Bucharest, București, 013764, Romania|Gama Diamed, Mangalia, Constanța, 905500, Romania|Diabmed Dr. Popescu Alexandrina, Ploiești, Prahova, 100179, Romania|Milena Sante, Galați, 800001, Romania|Clinica Korall, Satu Mare, 440055, Romania|MEDIKALS, Piešťany, 921 01, Slovakia|ProDia s.r.o., Povazska Bystrica, 017 01, Slovakia|JAL, Trnava, 917 01, Slovakia|IRIDIA, Vrutky, Žilinský Kraj, 038 61, Slovakia|Aberdeen Royal Infirmary, Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom|Ninewells Hospital and Medical School, Dundee, Angus, DD1 9SY, United Kingdom|Staploe Medical Centre, Ely, Cambridgeshire, CB7 5JD, United Kingdom|Knowle House Surgery, Plymouth, Devon, PL5 3JB, United Kingdom|Hull Royal Infirmary, Hull, Kingston Upon Hull, HU3 2JZ, United Kingdom|Leicester General Hospital, Leicester, Leicestershire, LE5 4PW, United Kingdom|Wickersley Health Centre - Clifton Medical Centre, Rotherham, S65 1DA, United Kingdom
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