| Outcome Measures: |
Primary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Safety was assessed by physical examinations, clinical laboratory parameters, electrocardiogram (ECG) readings, vital sign measurements, oral temperature, and hypoglycemic events. Changes in laboratory values or ECG parameters were considered to be adverse events if they were judged to be clinically significant. A TEAE was any event that started on or after the first dose of open-label study drug and within 14 days after the last dose., 4 years | Secondary: Change From Baseline Over Time in Glycosylated Hemoglobin, The change from Baseline in glycosylated hemoglobin (HbA1c; the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) during the study. Endpoint was defined as the last postbaseline observation collected within 7 days after the last dose of open-label study drug., Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42 and 45.|Change From Baseline in Fasting Plasma Glucose, The change from Baseline in fasting plasma glucose (FPG) at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug., Baseline and Year 4|Percentage of Participants With Marked Hyperglycemia, Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL (≥11.10 mmol/L). The Month 42 to Month 45 interval includes all marked hyperglycemic episodes occurring on or after Day 1247 (a 203-day visit window)., Randomization up to 4 years.|Change From Baseline in Proinsulin Level, Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug. Note: A transcription error occurred in the reporting of 1 proinsulin value for a patient in the alogliptin 25 mg completed group, for whom a partial patient ID number was mistakenly entered as an end-of-treatment proinsulin level., Baseline and Year 4|Change From Baseline in Insulin Level, The change from Baseline in fasting insulin at the last post-baseline observation, collected within 7 days after the last dose of open-label study drug., Baseline and Year 4|Change From Baseline in C-peptide Level, C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline to the last post-baseline observation, collected within 7 days after the last dose of open-label study drug., Baseline and Year 4|Change From Baseline in Body Weight, Change from Baseline in body weight to the last post-baseline observation collected within 7 days after the last dose of open-label study drug., Baseline and Year 4|Percentage of Participants With a Clinical Response, Clinical response was defined based on the absolute value of HbA1c meeting one of two clinical targets at any post-baseline visit: * HbA1c ≤6.5%; * HbA1c ≤7.0%., Weeks 2, 4, 8, 12, every 3 months up to 4 years, and 1 Day after final dose.
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| Locations: |
Birmingham, Alabama, United States|Peoria, Arizona, United States|Phoenix, Arizona, United States|Anaheim, California, United States|Artesia, California, United States|Fresno, California, United States|Los Angeles, California, United States|Mission Viejo, California, United States|Northridge, California, United States|Orange, California, United States|San Diego, California, United States|Tustin, California, United States|Walnut Creek, California, United States|Colorado Springs, Colorado, United States|Denver, Colorado, United States|Norwalk, Connecticut, United States|Washington, District of Columbia, United States|Clearwater, Florida, United States|Hollywood, Florida, United States|Kissimmee, Florida, United States|Longwood, Florida, United States|New Port Richie, Florida, United States|Ocala, Florida, United States|Ocoee, Florida, United States|St. Cloud, Florida, United States|Lawrenceville, Georgia, United States|Honolulu, Hawaii, United States|Idaho Falls, Idaho, United States|Chicago, Illinois, United States|Avon, Indiana, United States|Elkhart, Indiana, United States|Evansville, Indiana, United States|Lafayette, Indiana, United States|Erlanger, Kentucky, United States|Baltimore, Maryland, United States|Sudbury, Massachusetts, United States|Chesterfield, Missouri, United States|St. Louis, Missouri, United States|Omaha, Nebraska, United States|Berlin, New Jersey, United States|Burlington, North Carolina, United States|Charlotte, North Carolina, United States|Morehead City, North Carolina, United States|Pinehurst, North Carolina, United States|Winston-Salem, North Carolina, United States|Cincinnatti, Ohio, United States|Dayton, Ohio, United States|Tulsa, Oklahoma, United States|Medford, Oregon, United States|Lansdale, Pennsylvania, United States|West Grove, Pennsylvania, United States|Charleston, South Carolina, United States|Columbia, South Carolina, United States|Simpsonville, South Carolina, United States|Bristol, Tennessee, United States|Cookeville, Tennessee, United States|Milan, Tennessee, United States|Dallas, Texas, United States|San Antonio, Texas, United States|Temple, Texas, United States|Texarkana, Texas, United States|Burlington, Vermont, United States|Buenos Aires, La Plata, Argentina|Buenos Aires, Moron, Argentina|Rosario, Sante Fe, Argentina|Buenos Aires, Argentina|Ciudadd Autonoma de Buenos Aires, Argentina|Cordoba, Argentina|Mar del Plata, Argentina|Fortaleza, Ceara, Brazil|Curitiba, Parana, Brazil|Porto Alegre, Rio Grande do Sul, Brazil|Mogi das Cruzes, Sao Paulo, Brazil|Santos, Sao Paulo, Brazil|Sao Paulo, Brazil|Santiago, Chile|Ostrava, Czech Republic|Prague, Czech Republic|Praha, Czech Republic|Sternberk, Czech Republic|Zlin, Czech Republic|Santo Domingo Oeste, Dominican Republic|Aschaffenburg, Germany|Berlin, Germany|Frankfurt, Germany|Hamburg, Germany|Hannover, Germany|Munich, Germany|Nuremberg, Germany|Schwerin, Germany|Wiesbaden, Germany|Witten, Germany|Guatemala, Guatemala|Almere, Netherlands|De Bilt, Netherlands|Geleen, Netherlands|Oud-Beijerland, Netherlands|Rotterdam, Netherlands|Zwijndrecht, Netherlands|Bellavista, Lima, Peru|San Isidro, Lima, Peru|Ica, Peru|Lima, Peru|Bytom, Poland|Kamieniec Zabkowicki, Poland|Krakow, Poland|Leczyca, Poland|Lodz, Poland|Radom, Poland|Pretoria, Gauteng, South Africa|Cape Town, Western Cape, South Africa|Somerset West, Western Cape, South Africa|Durban, South Africa|Johannesburg, South Africa|Parow, South Africa
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