| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin at Week 52., The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline., Baseline and Week 52. | Secondary: Change From Baseline in Glycosylated Hemoglobin, The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated including final visit relative to baseline., Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.|Incidence of Hypoglycemia, Percentage of participants with at least one hypoglycemic episode during 52 week study., On occurrence (up to 52 weeks).|Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL)., The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study., On Occurrence (up to 52 weeks).|Incidence of Hyperglycemic Rescue, The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study., On Occurrence (up to 52 weeks).|Change From Baseline in Fasting Plasma Glucose, The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline., Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.|Change From Baseline in 2-hour Postprandial Glucose, The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink., Baseline and Week 52.|Change From Baseline in Fasting Proinsulin, The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline., Baseline, Week 12, Week 26, Week 42 and Week 52.|Change From Baseline in Insulin, The change between the value of insulin collected at each week indicated including final visit relative to baseline., Baseline, Week 12, Week 26, Week 42 and Week 52.|Change From Baseline in Proinsulin/Insulin Ratio, The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline., Baseline, Week 12, Week 26, Week 42 and Week 52.|Homeostasis Model Assessment of Beta Cell Function, The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5)., Baseline, Week 12, Week 26, Week 42 and Week 52.|Change From Baseline in Body Weight, The change in body weight measured at each week indicated including final visit from baseline., Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|Change From Baseline in Serum Lipids (Total Cholesterol), The change in total cholesterol measured at each week indicated including final visit from baseline., Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol), The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline., Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol), The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline., Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|Change From Baseline in Serum Lipids (Triglycerides), The change in triglycerides measured at each week indicated including final visit from baseline., Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|Change From Baseline in High Sensitivity C-reactive Protein, The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline., Baseline, Week 12, Week 26, Week 42 and Week 52.|Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%, The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study., Baseline and Week 52.|Incidence of Glycosylated Hemoglobin Decrease From Baseline., The percentage of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5, 1.0, 1.5 and 2.0% during the 52 week study., Baseline and Week 52.
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| Locations: |
Alexander City, Alabama, United States|Foothill Ranch, California, United States|Huntington Park, California, United States|Long Beach, California, United States|Los Angeles, California, United States|Redlands, California, United States|Prospect, Connecticut, United States|Bradenton, Florida, United States|Fort Myers, Florida, United States|Miami, Florida, United States|Ormond Beach, Florida, United States|Winter Park, Florida, United States|Roswell, Georgia, United States|Aurora, Illinois, United States|LaPorte, Indiana, United States|South Bend, Indiana, United States|Salisbury, Maryland, United States|Clarkston, Michigan, United States|Omaha, Nebraska, United States|Hamilton, New Jersey, United States|Albuquerque, New Mexico, United States|Beachwood, Ohio, United States|Westlake, Ohio, United States|Zanesville, Ohio, United States|Bensalem, Pennsylvania, United States|Aiken, South Carolina, United States|Greenville, South Carolina, United States|Greer, South Carolina, United States|Taylors, South Carolina, United States|Corpus Christi, Texas, United States|Dallas, Texas, United States|Pasadena, Texas, United States|San Antonio, Texas, United States|Tomball, Texas, United States|Ogden, Utah, United States|Salt Lake City, Utah, United States|Budapest, Hungary|Miskoic, Hungary|Nyiregyhaza, Hungary|Karnal, Haryana, India|Bangalore, Karnataka, India|Belgaum, Karnataka, India|Mumbai, Maharashrta, India|Ashkelon, Israel|Haifa, Israel|Holon, Israel|Nahariya, Israel|Rishon Le-Zion, Israel|Zefat, Israel|Saltillo, Coahuila, Mexico|Pachuca, Hidalgo, Mexico|Morelia, Michoacan, Mexico|Monterrey, Nuevo Leon, Mexico|Aguascalientes, Mexico|Durango, Mexico|Guadalajara, Mexico|Mexico DF, Mexico|Nezahualcoyotl, Mexico|Arequipa, Peru|Lima, Peru|Piura, Peru|Gdansk, Poland|Krakow, Poland|Warszawa, Poland|Baia Mare, Romania|Brasov, Romania|Bucharest, Romania|Galati, Romania|Satu Mare, Romania|Arkhangelsk, Russian Federation|Irkutsk, Russian Federation|Smolensk, Russian Federation|Cape Town, South Africa|Centurion, South Africa|Durban, South Africa|Johannesburg, South Africa|Port Elizabeth, South Africa|Pretoria, South Africa|Donetsk, Ukraine|Kharkiv, Ukraine
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