| Outcome Measures: |
Primary: The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia, A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention., 24 Weeks | Secondary: Percentage of Patients Achieving HbA1c <=7% at Week 24, This is a component of the primary endpoint, 24 Weeks|Percentage of Patients With no Weight Gain at Week 24, This is a component of the primary endpoint, 24 Weeks|Percentage of Patients With a Severe Hypoglycemia Adverse Event, This is a component of the primary endpoint., 24 Weeks|Change in HbA1c From Baseline at Week 24, Baseline values are presented in the Baseline Characteristics section, From Baseline to Week 24|Change in Body Weight From Baseline at Week 24, Baseline values are presented in the Baseline Characteristics section, From Baseline to Week 24|Change in Waist Circumference From Baseline at Week 24, Baseline values are presented in the Baseline Characteristics section, From Baseline to Week 24|Change in Fasting Plasma Glucose From Baseline at Week 24, Baseline values are presented in the Baseline Characteristics section, From Baseline to Week 24|Fasting Serum Lipids Change From Baseline to Week 24, Baseline, week 24|Phase 2: Change in HbA1c at Week 36, Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only)., Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36|Phase 2: Change in Body Weight at Week 36, Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only)., Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36 | Other: Hypoglycemia Adverse Events, MILD: patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms did not greatly interrupt or interfere with the patients daily activities. Symptoms dissipated spontaneously or upon eating. MODERATE: Patient reported symptoms consistent with hypoglycemia that may or may not have been documented by glucose monitoring at the time of symptoms. Symptoms interrupted or interfered with the patients daily activities and required immediate self treatment (e.g. carbohydrate ingestion). SEVERE: Patient required the assistance of another individual (including aid in ingestion of oral carbohydrate): and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention., 36 weeks
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| Locations: |
Research Site, Northport, Alabama, United States|Research Site, Phoenix, Arizona, United States|Research Site, Loma Linda, California, United States|Research Site, Aurora, Colorado, United States|Research Site, Hollywood, Florida, United States|Research Site, Maitland, Florida, United States|Research Site, Miami, Florida, United States|Research Site, North Miami Beach, Florida, United States|Research Site, Plantation, Florida, United States|Research Site, Roswell, Georgia, United States|Research Site, Peoria, Illinois, United States|Research Site, Indianapolis, Indiana, United States|Research Site, Wichita, Kansas, United States|Research Site, Lexington, Kentucky, United States|Research Site, Baton Rouge, Louisiana, United States|Research Site, Baltimore, Maryland, United States|Research Site, Detroit, Michigan, United States|Research Site, Grand Rapids, Michigan, United States|Research Site, Jackson, Mississippi, United States|Research Site, St. Louis, Missouri, United States|Research Site, Butte, Montana, United States|Research Site, Las Vegas, Nevada, United States|Research Site, Hamilton, New Jersey, United States|Research Site, Albuquerque, New Mexico, United States|Research Site, Albany, New York, United States|Research Site, Staten Island, New York, United States|Research Site, Mentor, Ohio, United States|Research Site, Portland, Oregon, United States|Research Site, Bridgeville, Pennsylvania, United States|Research Site, Philadelphia, Pennsylvania, United States|Research Site, Aiken, South Carolina, United States|Research Site, Bartlett, Tennessee, United States|Research Site, Nashville, Tennessee, United States|Research Site, Austin, Texas, United States|Research Site, Dallas, Texas, United States|Research Site, Olympia, Washington, United States|Research Site, Spokane, Washington, United States
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