| Outcome Measures: |
Primary: Change from baseline in glycosylated hemoglobin, Week 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|Change from baseline in 1,5-Anhydroglucitol, Weeks 2, 4, 8, and 12 or Final Visit.|Change from baseline in Proinsulin, Weeks 4, 8, and 12 or Final Visit.|Change from baseline in Insulin, Weeks 4, 8, and 12 or Final Visit.|Change from baseline in Proinsulin/insulin ratio, Weeks 4, 8, and 12 or Final Visit.|Change from baseline in C-peptide, Weeks 4, 8, and 12 or Final Visit.|Change from baseline in Homeostasis model assessment of insulin resistance., Weeks: 4, 8, and 12 or Final Visit.|Change from baseline in Homeostasis model assessment of beta-cell function., Weeks 4, 8, and 12 or Final Visit.|Incidence of marked hyperglycemia (fasting plasma glucose greater than or equal to 200 mg/dL [11.10 mmol/L])., 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.
|
| Locations: |
Birmingham, Alabama, United States|Mobile, Alabama, United States|Montgomery, Alabama, United States|Phoenix, Arizona, United States|Tempe, Arizona, United States|Tucson, Arizona, United States|Anderson, Arkansas, United States|Little Rock, Arkansas, United States|Pine Bluff, Arkansas, United States|Carmichael, California, United States|Chino, California, United States|Long Beach, California, United States|Los Angeles, California, United States|Los Gatos, California, United States|Orange, California, United States|Pico Rivera, California, United States|Rolling Hills Estates, California, United States|Roseville, California, United States|Rowland Heights, California, United States|Sacramento, California, United States|Santa Ana, California, United States|Stockton, California, United States|Torrance, California, United States|Arvada, Colorado, United States|Colorado Springs, Colorado, United States|Highlands Ranch, Colorado, United States|Avon, Connecticut, United States|Rocky Hill, Connecticut, United States|Newark, Delaware, United States|Aventura, Florida, United States|Edgewater, Florida, United States|Hollywood, Florida, United States|Jacksonville, Florida, United States|Kissimmee, Florida, United States|Merritt Island, Florida, United States|Miami, Florida, United States|New Port Richey, Florida, United States|Ocala, Florida, United States|Pembroke Pines, Florida, United States|Tampa, Florida, United States|Zanesville, Florida, United States|Atlanta, Georgia, United States|Roswell, Georgia, United States|Waycross, Georgia, United States|Idaho Falls, Idaho, United States|Chicago, Illinois, United States|Avon, Indiana, United States|Fort Wayne, Indiana, United States|Des Moines, Iowa, United States|Waterloo, Iowa, United States|Topeka, Kansas, United States|Wichita, Kansas, United States|Crestview, Kentucky, United States|Oxon Hill, Maryland, United States|Detroit, Michigan, United States|Troy, Michigan, United States|Olive Branch, Mississippi, United States|Kansas City, Missouri, United States|St. Louis, Missouri, United States|Omaha, Nebraska, United States|Las Vegas, Nevada, United States|West Caldwell, New Jersey, United States|Wildwood Crest, New Jersey, United States|Albuquerque, New Mexico, United States|East Islip, New York, United States|Lewiston, New York, United States|New York, New York, United States|North Massapequa, New York, United States|Wantagh, New York, United States|Hickory, North Carolina, United States|Statesville, North Carolina, United States|Tabor City, North Carolina, United States|Bismarck, North Dakota, United States|Cincinnati, Ohio, United States|Columbus, Ohio, United States|Mason, Ohio, United States|Wadsworth, Ohio, United States|Norman, Oklahoma, United States|Oklahoma City, Oklahoma, United States|Tulsa, Oklahoma, United States|Eugene, Oregon, United States|Medford, Oregon, United States|Bensalem, Pennsylvania, United States|Connellsville, Pennsylvania, United States|Philadelphia, Pennsylvania, United States|Pittsburgh, Pennsylvania, United States|Shippensburg, Pennsylvania, United States|Charleston, South Carolina, United States|Greer, South Carolina, United States|North Myrtle Beach, South Carolina, United States|Chattanooga, Tennessee, United States|Memphis, Tennessee, United States|New Tazewell, Tennessee, United States|Carrolton, Texas, United States|Dallas, Texas, United States|Georgetown, Texas, United States|Houston, Texas, United States|Killeen, Texas, United States|San Antonio, Texas, United States|Salt Lake City, Utah, United States|Spanish Fork, Utah, United States|Richmond, Virginia, United States|Suffolk, Virginia, United States|Virginia Beach, Virginia, United States|Spokane, Washington, United States|Zapopan, Jalisco, Mexico|Monterrey, Nuevo Leon, Mexico|Mexico DF, Mexico|Monterrey, Mexico|Nezahualcoyotl, Mexico|Puebla, Mexico|Veracruz, Mexico
|
