| Outcome Measures: |
Primary: Change in HbA1c From Baseline to Week 24, Change in HbA1c from baseline (Day 1) to Week 24 \[Week 24 - Baseline\]., Day 1, Week 24 | Secondary: Percentage of Subjects Achieving HbA1c Target of <7%, Percentages of subjects achieving HbA1c target value of \<7% at Week 24., Week 24|Percentage of Subjects Achieving HbA1c Target of <=6.5%, Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 24., Week 24|Change in Fasting Plasma Glucose From Baseline to Week 24, Change in fasting plasma glucose from baseline (Day 1) to Week 24., Day 1, Week 24|Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL, Percentages of subjects achieving fasting plasma glucose target of \<=126 mg/dL at Week 24., Week 24|Change in Body Weight From Baseline to Week 24, Change in body weight from baseline (Day 1) to Week 24., Day 1, Week 24|Change in Sitting Systolic Blood Pressure From Baseline to Week 24, Change in systolic blood pressure from baseline (Day 1) to Week 24., Day 1, Week 24|Change in Sitting Diastolic Blood Pressure From Baseline to Week 24, Change in diastolic blood pressure from baseline (Day 1) to Week 24., Day 1, Week 24|Change in Total Cholesterol From Baseline to Week 24, Change in total cholesterol from baseline (Day 1) to Week 24., Day 1, Week 24|Change in High-density Lipoprotein (HDL) From Baseline to Week 24, Change in HDL from baseline (Day 1) to Week 24., Day 1, Week 24|Ratio of Triglycerides at Week 24 to Baseline, Ratio of triglycerides (measured in mg/dL) at Week 24 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline., Day 1, Week 24|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events, The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject., Day 1 to Week 24|Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events, The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia., Day 1 to Week 24
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| Locations: |
Research Site, Birmingham, Alabama, United States|Research Site, Mesa, Arizona, United States|Research Site, Peoria, Arizona, United States|Research Site, Artesia, California, United States|Research Site, Concord, California, United States|Research Site, Encino, California, United States|Research Site, Greenbrae, California, United States|Research Site, La Mesa, California, United States|Research Site, Walnut Creek, California, United States|Research Site, DeLand, Florida, United States|Research Site, Hialeah, Florida, United States|Research Site, Miami, Florida, United States|Research Site, New Port Richey, Florida, United States|Research Site, Palm Harbor, Florida, United States|Research Site, Chicago, Illinois, United States|Research Site, Avon, Indiana, United States|Research Site, Evansville, Indiana, United States|Research Site, Lexington, Kentucky, United States|Research Site, Paducah, Kentucky, United States|Research Site, Detroit, Michigan, United States|Research Site, Edina, Minnesota, United States|Research Site, St. Louis, Missouri, United States|Research Site, Butte, Montana, United States|Research Site, New Hyde Park, New York, United States|Research Site, Rochester, New York, United States|Research Site, Raleigh, North Carolina, United States|Research Site, Statesville, North Carolina, United States|Research Site, Cincinnati, Ohio, United States|Research Site, Delaware, Ohio, United States|Research Site, Mentor, Ohio, United States|Research Site, Eugene, Oregon, United States|Research Site, Rapid City, South Dakota, United States|Research Site, Austin, Texas, United States|Research Site, Corpus Christi, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, Burke, Virginia, United States|Research Site, Manassas, Virginia, United States|Research Site, Richmond, Virginia, United States|Research Site, Olympia, Washington, United States|Research Site, Spokane, Washington, United States|Research Site, Tacoma, Washington, United States
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