| Outcome Measures: |
Primary: Change from baseline in glycosylated hemoglobin, Weeks 12 or Final Visit. | Secondary: Change from baseline in glycosylated hemoglobin, Weeks 4, 8, and 12 or Final Visit.|Change from baseline in fasting plasma glucose, Weeks 1, 2, 4, 8, and 12 or Final Visit.|1,5-Anhydroglucitol, Weeks 2, 4, 8, and 12 or Final Visit.|Change in Proinsulin, Weeks 4, 8, and 12 or Final Visit.|Change in Proinsulin/insulin ratio, Weeks 4, 8, and 12 or Final Visit.|Change in baseline C-peptide, Weeks 4, 8, and 12 or Final Visit.|Change from baseline in insulin, Weeks 4, 8, and 12 or Final Visit.|Change in Homeostasis model assessment of beta cell function, Weeks 4, 8, and 12 or Final Visit.|Change in Homeostasis model assessment of insulin resistance, Weeks 4, 8, and 12 or Final Visit|Incidence of rescue, Weeks 1, 2, 4, 8, and 12 or Final Visit.|Clinical response endpoint incidence of glycosylated hemoglobin less than or equal to 6.5%, Week 12 or Final Visit|Clinical response endpoint incidence of glycosylated hemoglobin less than or equal to 7.0%, Week 12 or Final Visit|Change from baseline in Fasting lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol), Weeks 4, 8, and 12 or Final Visit|Body weight, Weeks 4, 8, and 12 or Final Visit.
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| Locations: |
Birmingham, Alabama, United States|Mobile, Alabama, United States|Montgomery, Alabama, United States|Pell City, Alabama, United States|Tallassee, Alabama, United States|Sierra Vista, Arizona, United States|Fountain Valley, California, United States|Los Angeles, California, United States|National City, California, United States|Pismo Beach, California, United States|Clearwater, Florida, United States|North Miami Beach, Florida, United States|Ocoee, Florida, United States|Orlando, Florida, United States|Plantation, Florida, United States|Dawsonville, Georgia, United States|Gainesville, Georgia, United States|Naperville, Illinois, United States|Elkhart, Indiana, United States|Indianapolis, Indiana, United States|Slidell, Louisiana, United States|Taunton, Massachusetts, United States|Ann Arbor, Michigan, United States|Great Falls, Montana, United States|Scottsbluff, Nebraska, United States|Las Vegas, Nevada, United States|Brooklyn, New York, United States|Charlotte, North Carolina, United States|Shelby, North Carolina, United States|Sparta, North Carolina, United States|Fargo, North Dakota, United States|Bensalem, Ohio, United States|Dayton, Ohio, United States|Kettering, Ohio, United States|Central Point, Oregon, United States|Altoona, Pennsylvania, United States|Providence, Rhode Island, United States|Clemson, South Carolina, United States|Columbia, South Carolina, United States|Greer, South Carolina, United States|Rapid City, South Dakota, United States|Cleveland, Tennessee, United States|Kingsport, Tennessee, United States|Arlington, Texas, United States|Fort Worth, Texas, United States|North Richland Hills, Texas, United States|San Antonio, Texas, United States|Spring, Texas, United States|Sugarland, Texas, United States|Hampton, Virginia, United States|Richmond, Virginia, United States|Santiago, Chile|Temuco, Chile|Ostrava, Czech Republic|Prague, Czech Republic|Guatemala, Guatemala|Quetzaltenango, Guatemala|Eger, Hungary|Szentes, Hungary|Riga, Latvia|Sigulda, Latvia|Valmiera, Latvia|Kaunas, Lithuania|Kedainiai, Lithuania|Klaipeda, Lithuania|Vilnius, Lithuania|Ponce, Puerto Rico|Alba Iulia, Romania|Baia Mare, Romania|Bihor, Romania|Brasov, Romania|Bucharest, Romania|Constanta, Romania|Ploiesti, Romania|Satu Mare, Romania|Targoviste, Romania|Kemerovo, Russian Federation|Moscow, Russian Federation|St. Petersburg, Russian Federation|Ufa, Russian Federation|Volgograd, Russian Federation|Yaroslavl, Russian Federation|Banska Bystrica, Slovakia|Bratislava, Slovakia|Presov, Slovakia|Kharkiv, Ukraine|Vinnytsya, Ukraine
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