A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment emergent AEs were events between first dose of study drug and approximately 4 weeks after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.

Leukocytes (10^9/liter [L]) bilirubin (micromol/L), glucose (millimoles [mmol]/L), triacylglycerol lipase (microkatals [microkat]/L): greater than (>) 1.5*upper limit normal (ULN); activated partial thromboplastin time (s): 1.1*ULN; HDL cholesterol (mmol/L), thyroid stimulating hormone (TSH) (milliunits [mU]/L): less than (<) 0.8*lower limit normal (LLN); LDL cholesterol (mmol/L), urate (mmol/L): >1.2*ULN; triglycerides: >1.3*ULN; aspartate aminotransferase (microkat/L), alanine aminotransferase (microkat/L), gamma glutamyl transferase (microkat/L): >3.0*ULN; cholesterol (mmol/L): >1.3*ULN; urine glucose, ketones urine protein, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase: greater than or equal to (>=) 1; granular casts, hyaline casts: >1.

Supine systolic blood pressure (SBP) measured in millimeter of mercury (mmHg) had following categories: minimum of absolute SBP <90 mmHg, maximum of SBP >=30 mmHg decrease from baseline and maximum of SBP >=30 mmHg increase from baseline. Supine diastolic blood pressure (DBP) measured in mmHg had following categories: minimum of absolute DBP <50 mmHg, maximum of DBP >20 mmHg decrease from baseline and maximum of DBP >=20 mmHg increase from baseline. Supine pulse rate measured in beats per minute (BPM) had following categories: minimum of absolute supine pulse rate <40 BPM and maximum of absolute supine pulse rate >120 BPM. Baseline was defined as the time-matched value from the average of the triplicate recordings on Day -1.

PR interval had following categories: maximum absolute PR interval >=300 milliseconds (msec); when baseline PR interval >200 msec and maximum increase from baseline in PR interval >=25 percent; when baseline PR interval less than or equal to (<=) 200 msec and maximum increase from baseline in PR interval >=50 percent. QRS interval had following categories: maximum absolute QRS interval >=140 msec; maximum increase from baseline in QRS interval >=50 percent. QTC interval with Frederica's correction (QTCF) had following categories: absolute QTCF interval >450 msec to <=480 msec; absolute QTCF interval >480 msec to <=500 msec; absolute QTCF interval >500 msec; QTCF interval increase from baseline >=30 msec to <=60 msec; QTCF interval increase from baseline >60 msec.

AUC24= Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).

t1/2 was calculated as loge (2) per kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.