| Outcome Measures: |
Primary: Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Mean change from baseline is adjusted for baseline value., Baseline, Week 24 | Secondary: Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Mean change from baseline is adjusted for baseline value., Baseline, Week 24|Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24, Week 24|Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC), Mean change from baseline is adjusted for baseline value., Baseline, Week 24 | Other: Overall Summary of Adverse Events During ST+LT Treatment Period, AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing., AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|Marked Laboratory Abnormalities - During ST + LT Treatment Period, A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: \<0.9 x Pre-Rx \& \<=130mEq/L / high: \>1.1 x Pre-Rx \& \>=150mEq/L; potassium, serum low: \<=0.8 x Pre-Rx \& \>=6.0mEq/L / high: 1.2 x Pre-Rx \& \>=6.0mEq/L; LLN=lower limit of normal., Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure: 124, 118, 130, 95 weeks, respectively, for 2.5mg, 5mg, 10 mg, placebo.|Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period, Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Baseline and Changes From Baseline in Hematocrit During the ST + LT Period, Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period, Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period, Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period, Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period, Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period, Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period, Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period, Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period, Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Changes From Baseline in Systolic Blood Pressure During the ST + LT Period, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Changes From Baseline in Heart Rate During the ST + LT Period, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206|Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period, The normality/abnormality of the ECG tracing was determined by the investigator., Baseline, Weeks 12, 24, 76, 102, 154, 206,|All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period, Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which are hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness., AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla|Confirmed Hypoglycemia During the ST + LT Treatment Period, 'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick glucose \<= 50 mg/dL and associated symptoms., AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla
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| Locations: |
Local Institution, Anniston, Alabama, United States|Local Institution, Birmingham, Alabama, United States|Local Institution, Calera, Alabama, United States|Local Institution, Haleyville, Alabama, United States|Local Institution, Mesa, Arizona, United States|Local Institution, Phoenix, Arizona, United States|Local Institution, Jonesboro, Arkansas, United States|Local Institution, Little Rock, Arkansas, United States|Local Institution, Sherwood, Arkansas, United States|Local Institution, Encino, California, United States|Local Institution, Fountain Valley, California, United States|Local Institution, Fresno, California, United States|Local Institution, Los Angeles, California, United States|Local Institution, Mission Viejo, California, United States|Local Institution, Northridge, California, United States|Local Institution, Orange, California, United States|Local Institution, Roseville, California, United States|Local Institution, Sacramento, California, United States|Local Institution, Spring Valley, California, United States|Local Institution, Tustin, California, United States|Local Institution, Castle Rock, Colorado, United States|Local Institution, Colorado Springs, Colorado, United States|Local Institution, Denver, Colorado, United States|Local Institution, Golden, Colorado, United States|Local Institution, Loveland, Colorado, United States|Local Institution, Altamonte Springs, Florida, United States|Local Institution, Chipley, Florida, United States|Local Institution, Cocoa Beach, Florida, United States|Local Institution, Coral Gables, Florida, United States|Local Institution, Fort Lauderdale, Florida, United States|Local Institution, Jacksonville, Florida, United States|Local Institution, Kissimmee, Florida, United States|Local Institution, Marianna, Florida, United States|Local Institution, Miami, Florida, United States|Local Institution, New Port Richey, Florida, United States|Local Institution, Ocala, Florida, United States|Local Institution, Tallahassee, Florida, United States|Local Institution, Tampa, Florida, United States|Local Institution, Decatur, Georgia, United States|Local Institution, Chicago, Illinois, United States|Local Institution, Vernon Hills, Illinois, United States|Local Institution, Elkhart, Indiana, United States|Local Institution, Lafayette, Indiana, United States|Local Institution, Iowa City, Iowa, United States|Local Institution, Waterloo, Iowa, United States|Local Institution, Topeka, Kansas, United States|Local Institution, Lexington, Kentucky, United States|Local Institution, Munfordville, Kentucky, United States|Local Institution, New Orleans, Louisiana, United States|Local Institution, West Monroe, Louisiana, United States|Local Institution, Baltimore, Maryland, United States|Local Institution, Chester, Maryland, United States|Local Institution, Prince Frederick, Maryland, United States|Local Institution, Boston, Massachusetts, United States|Local Institution, Kansas City, Missouri, United States|Local Institution, St. Louis, Missouri, United States|Local Institution, Kalispell, Montana, United States|Local Institution, Omaha, Nebraska, United States|Local Institution, Las Vegas, Nevada, United States|Local Institution, Toms River, New Jersey, United States|Local Institution, Albuquerque, New Mexico, United States|Local Institution, Charlotte, North Carolina, United States|Local Institution, Greensboro, North Carolina, United States|Local Institution, Morehead City, North Carolina, United States|Local Institution, Salisbury, North Carolina, United States|Local Institution, Sparta, North Carolina, United States|Local Institution, Wilmington, North Carolina, United States|Local Institution, Winston Salem, North Carolina, United States|Local Institution, Athens, Ohio, United States|Local Institution, Columbus, Ohio, United States|Local Institution, Lyndhurst, Ohio, United States|Local Institution, Oklahoma City, Oklahoma, United States|Local Institution, Tulsa, Oklahoma, United States|Local Institution, Eugene, Oregon, United States|Local Institution, Portland, Oregon, United States|Local Institution, Carlisle, Pennsylvania, United States|Local Institution, Langhorne, Pennsylvania, United States|Local Institution, Levittown, Pennsylvania, United States|Local Institution, Philadelphia, Pennsylvania, United States|Local Institution, Pittsburgh, Pennsylvania, United States|Local Institution, Charleston, South Carolina, United States|Local Institution, Duncan, South Carolina, United States|Local Institution, Bristol, Tennessee, United States|Local Institution, Austin, Texas, United States|Local Institution, Bryan, Texas, United States|Local Institution, Carrollton, Texas, United States|Local Institution, Dallas, Texas, United States|Local Institution, Houston, Texas, United States|Local Institution, San Antonio, Texas, United States|Local Institution, Temple, Texas, United States|Local Institution, Salt Lake City, Utah, United States|Local Institution, Hampton, Virginia, United States|Local Institution, Virginia Beach, Virginia, United States|Local Institution, Olympia, Washington, United States|Local Institution, Spokane, Washington, United States|Local Institution, Mar Del Plata, Buenos Aires, Argentina|Local Institution, Rosario, Santa Fe, Argentina|Local Institution, Buenos Aires, Argentina|Local Institution, Cordoba, Argentina|Local Institution, Sydney, New South Wales, Australia|Local Institution, Woollongong, New South Wales, Australia|Local Institution, Brisbane, Queensland, Australia|Local Institution, Kippa Ring, Queensland, Australia|Local Institution, Meadowbrook, Queensland, Australia|Local Institution, Adelaide, South Australia, Australia|Local Institution, Woodville South, South Australia, Australia|Local Institution, Perth, Western Australia, Australia|Local Institution, Fortaleza, Ceara, Brazil|Local Institution, Belem, Para, Brazil|Local Institution, Porto alegre, Rio Grande Do Sul, Brazil|Local Institution, Campinas, Sao Paulo, Brazil|Local Institution, Marilia, Sao Paulo, Brazil|Local Institution, Sao Paulo, Brazil|Local Institution, Calgary, Alberta, Canada|Local Institution, Coquitlam, British Columbia, Canada|Local Institution, Kelowna, British Columbia, Canada|Local Institution, Surrey, British Columbia, Canada|Local Institution, Brandon, Manitoba, Canada|Local Institution, Portage La Prairie, Manitoba, Canada|Local Institution, Winnipeg, Manitoba, Canada|Local Institution, Bathurst, New Brunswick, Canada|Local Institution, Mount Pearl, Newfoundland and Labrador, Canada|Local Institution, St. John's, Newfoundland and Labrador, Canada|Local Institution, St. Johns, Newfoundland and Labrador, Canada|Local Institution, Aylmer, Ontario, Canada|Local Institution, London, Ontario, Canada|Local Institution, Oakville, Ontario, Canada|Local Institution, Sarnia, Ontario, Canada|Local Institution, Thornhill, Ontario, Canada|Local Institution, Toronto, Ontario, Canada|Local Institution, Woodstock, Ontario, Canada|Local Institution, Charlottetown, Prince Edward Island, Canada|Local Institution, Drummondville, Quebec, Canada|Local Institution, Fleurimont, Quebec, Canada|Local Institution, Longueuil, Quebec, Canada|Local Institution, St. Leonard, Quebec, Canada|Local Institution, Saskatoon, Saskatchewan, Canada|Local Institution, Santiago De Chile, Metropolitana, Chile|Local Institution, Santiago, Metropolitana, Chile|Local Institution, Celaya, Guanajuato, Mexico|Local Institution, Guadalajara, Jalisco, Mexico|Local Institution, Morelia, Michioacan, Mexico|Local Institution, Monterrey, Nuevo Leon, Mexico|Local Institution, Hermosillo, Sonora, Mexico|Local Institution, Merida, Yucatan, Mexico|Local Institution, Distrito Federal, Mexico|Local Institution, Durango, Mexico|Local Institution, Carolina, Puerto Rico|Local Institution, Ponce, Puerto Rico|Local Institution, Rio Pieoras, Puerto Rico|Local Institution, San Juan, Puerto Rico|Local Institution, Hualien, Taiwan|Local Institution, Taichung, Taiwan|Local Institution, Taipei, Taiwan
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