| Outcome Measures: |
Primary: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between, Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between, Baseline, Week 4, Week 8, Week 12, Week 16|Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose, Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime), Baseline, Week 16 | Secondary: Percentage of subjects reaching the target HbA1c (<7%), The percentage of subjects reaching the target HbA1c (\<7%) will be summarized and compared by treatment, Baseline, Week 2, Week 4, Week 8, Week 12, Week 16|Change in body weight from Baseline to Week 16, Change in body weight (kg) from Baseline to Week 16, Baseline, Week 16|Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose, Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime), Baseline, Week 16|Changes in beta cell function and insulin sensitivity between Baseline and Week 16, Changes in beta cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses and the proinsulin/insulin ratio Between Baseline and Week 16, Baseline, Week 16|Changes in lipids between Baseline and Week 16, Changes from Baseline to Week 16 in serum lipids (total cholesterol \[TC\], high-density lipoprotein cholesterol \[HDL-C\], fasting triglycerides, calculated low-density lipoprotein cholesterol \[LDL-C\], Baseline, Week 16
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| Locations: |
Research Site, Birmingham, Alabama, United States|Research Site, La Jolla, California, United States|Research Site, San Mateo, California, United States|Research Site, Santa Barbara, California, United States|Research Site, Spring Valley, California, United States|Research Site, Hialeah, Florida, United States|Research Site, Jacksonville, Florida, United States|Research Site, Melbourne, Florida, United States|Research Site, West Palm Beach, Florida, United States|Research Site, Atlanta, Georgia, United States|Research Site, Honolulu, Hawaii, United States|Research Site, Idaho Falls, Idaho, United States|Research Site, Chicago, Illinois, United States|Research Site, Baton Rouge, Louisiana, United States|Research Site, Kalamazoo, Michigan, United States|Research Site, Troy, Michigan, United States|Research Site, Butte, Montana, United States|Research Site, McCook, Nebraska, United States|Research Site, North Platte, Nebraska, United States|Research Site, Omaha, Nebraska, United States|Research Site, Scottsbluff, Nebraska, United States|Research Site, Princeton, New Jersey, United States|Research Site, Albuquerque, New Mexico, United States|Research Site, Albany, New York, United States|Research Site, New York, New York, United States|Research Site, Rochester, New York, United States|Research Site, Greenville, North Carolina, United States|Research Site, Cleveland, Ohio, United States|Research Site, Greenville, South Carolina, United States|Research Site, Chattanooga, Tennessee, United States|Research Site, Knoxville, Tennessee, United States|Research Site, Dallas, Texas, United States|Research Site, Georgetown, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, The Colony, Texas, United States|Research Site, Olympia, Washington, United States|Research Site, Renton, Washington, United States|Research Site, Tacoma, Washington, United States|Research Site, Charleston, West Virginia, United States|Research Site, Huntington, West Virginia, United States|Research Site, Calgary, Alberta, Canada|Research Site, Vancouver, British Columbia, Canada|Research Site, Dartmouth, Nova Scotia, Canada|Research Site, London, Ontario, Canada|Research Site, Toronto, Ontario, Canada|Research Site, Montreal, Quebec, Canada|Research Site, Granada, Spain|Research Site, Sevilla, Spain|Research Site, Valencia, Spain|Research Site, Valladolid, Spain|Research Site, Zaragoza, Spain
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