Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)

Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast.

Time frame: Day 16 (Predose)

Population: The analysis population was participants who complied with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model. Compliance covered such considerations as exposure to treatment, availability of measurements and absence of major protocol violations.

An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Time frame: Up to 17 days

Population: All participants who received at least one dose of the investigational drug.

An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Time frame: Up to 14 days after the last dose of study drug (Up to 31 days)

Population: All participants who received at least one dose of the investigational drug.

The WMG provides an integrated assessment of the glycemic exposure over the 24-hour period. To reduce variability of the baseline (before any study drug administration) WMG, participants were domiciled in the test facility at least 36 hours prior to Day 1, where standard meals were provided, and physical activity was monitored. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The sample scheme for the 18 point glucose measurements used in this study had many samples taken in the very early morning hours, as well as the first three hours after meals. WMG was calculated as the area under the curve (AUC) of the glucose concentrations divided by the duration of time of samples collected.

Time frame: Day 15: Predose, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 21, 23 hours post-dose.

Population: The analysis population was participants who complied with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model. Compliance covered such considerations as exposure to treatment, availability of measurements and absence of major protocol violations.

Plasma glucose excursion was assessed during an oral glucose tolerance test (oGTT) following a single dose administration of MK-8655 in participants with T2DM.

Time frame: Baseline and 2 hours after dosing on Days 1, 3, and 16

Population: The analysis population was participants who complied with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model. Compliance covered such considerations as exposure to treatment, availability of measurements and absence of major protocol violations.

C24hr was log transformed and analyzed based on a linear mixed effects model containing fixed effects for treatment, day and treatment by day interaction and a random effect for the participant.

Time frame: 24 hours post dose on Days 1, 7, and 14

Population: The analysis population was participants who complied with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model. No pharmacokinetic analysis for C24 was performed for participants receiving placebo.