| Outcome Measures: |
Primary: Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12, Mean change was adjusted for baseline., Baseline, Week 12 | Secondary: Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG), Mean change was adjusted for baseline., Baseline, Week 12|Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12, Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.), Week 12|Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12, Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.), Week 12 | Other: Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary, AE = any new untoward medical occurrence/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. Treatment-related=Possible, Probable, or Certain relationship to drug., Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the double-blind (DB) period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period, Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness., Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|Participants With Confirmed Hypoglycemia, Confirmed hypoglycemia was defined by a fingerstick glucose value \<= 50 mg/dL with associated hypoglycemia symptoms., Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|Participant Electrocardiogram (ECG) Status at Baseline and Week 12, Abnormal ECGs were defined as those not within the normal limits for the participant, according to the investigator. 'Shifted Normal to Abnormal' and 'Shifted Abnormal to Normal' references a change from measurements at Baseline to those at Week 12., Baseline, Week 12|Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Baseline values reference the measurement for the cohort of participants evaluated at the given time point., Baseline, Week 4, Week 8, Week 12|Baseline and Mean Change From Baseline in Participant Heart Rate (HR), Baseline values reference the measurement for the cohort of participants evaluated at the given time point., Baseline, Week 4, Week 8, Week 12|Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria, 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. ULN=upper limit of normal; LLN=lower limit of normal., Baseline, Week 12|Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria, Marked abnormality criteria were urine protein: if pre-Rx=o use \>=2, if pre-Rx =0.5 or 1 use \>=3, if pre-Rx =2, use \>=4; urine blood: if pre-Rx=0, use \>=2, if pre-Rx=0.5 or 1, use \>=3, if pre-Rx=2, use \>=4; Urine red blood cell count (RBC): if pre-Rx=o use \>=2, if pre-Rx =0.5 or 1 use \>=3, if pre-Rx =2, use \>=4; urine white blood cell count (WBC): if pre-Rx=o use \>=2, if pre-Rx =0.5 or 1 use \>=3, if pre-Rx =2, use \>=4., Baseline, Week 12
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| Locations: |
John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States|Southland Clinical Research Center, Inc., Fountain Valley, California, 92708, United States|Torrance Clinical Research, Lomita, California, 90717, United States|Ritchken & First M.D.'S, San Diego, California, 92117, United States|Central Florida Clinical Trials, Inc., Altamonte Springs, Florida, 32701, United States|Family Care Associates Of Nw Florida, Chipley, Florida, 32428, United States|Clinical Therapeutics Corporation, Coral Gables, Florida, 33134, United States|Nextphase Clinical Trials, Inc., Miami, Florida, 33145, United States|Middle Georgia Drug Study Center, Llc, Perry, Georgia, 31069, United States|Louisiana Heart Center Research, Slidell, Louisiana, 70458, United States|Jackson Clinic, Rolling Fork, Mississippi, 39159, United States|Community Health Care Of Manchester, Akron, Ohio, 44319, United States|Midwest Regional Research, Inc., Bellbrook, Ohio, 45305, United States|Wells Institute For Health Awareness, Kettering, Ohio, 45429, United States|Newark Physician Associates, Newark, Ohio, 43055, United States|Integris Family Care South, Oklahoma, Oklahoma, 73170, United States|Integris Family Care Yukon, Yukon, Oklahoma, 73099, United States|Williamette Valley Clinical Studies, Eugene, Oregon, 97404, United States|Integrated Medical Group Pc/Fleetwood Clinical Research, Fleetwood, Pennsylvania, 19522, United States|Southeastern Research Associates, Inc, Taylors, South Carolina, 29687, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Village Family Practice, Houston, Texas, 77024, United States|Southwest Clinical Research Centers, Llc, Pearland, Texas, 77584, United States|Jolene K. Berg, Md., Dgd Research, Inc., San Antonio, Texas, 78229, United States|Tidewater Integrated Medical Research, Virginia Beach, Virginia, 23454, United States|Local Institution, Ludwigshafen, 67067, Germany|Local Institution, Magdeberg, 39112, Germany|Local Institution, Pirna, 01796, Germany|Local Institution, Saarbrucken, 66119, Germany|Local Institution, Saarlouis, 66740, Germany|Local Institution, Tann, 36142, Germany|Local Institution, Wuestensachsen, 36115, Germany|Local Institution, Balatonfured, 8230, Hungary|Local Institution, Budapest, 1036, Hungary|Local Institution, Eger, 3300, Hungary|Local Institution, Szigetvar, 7900, Hungary|Local Institution, Zalaegerszeg, 8900, Hungary|Local Institution, Ponce, 00716, Puerto Rico|Local Institution, San Juan, 00909, Puerto Rico|Local Institution, San Juan, 00920, Puerto Rico|Local Institution, San Juan, 00926, Puerto Rico
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