Mean change was adjusted for baseline.

Randomized participants with a measurement at the specified timepoint with Last Observation Carried Forward (LOCF).

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.)

Randomized participants with measurement at timepoint with LOCF.

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.)

Randomized participants with measurement at timepoint with LOCF.

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.

All treated participants.

Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.

All treated participants.

Confirmed hypoglycemia was defined by a fingerstick glucose value <= 50 mg/dL with associated hypoglycemia symptoms.

All treated participants.

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.

All treated participants, excluding those with missing values.

Baseline values reference the measurement for the cohort of participants evaluated at the given time point.

All treated participants. n= number of participants with measurement at time point.

Baseline values reference the measurement for the cohort of participants evaluated at the given time point.

All treated participants. n= number of participants with measurement at time point.

Mean change was adjusted for baseline.

Randomized participants with both a baseline value and post-baseline value (up to Week 12).

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.

All treated participants.

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.

All treated participants. N = number of participants analyzed and n = the number of participants with values available for each specific measurement.