Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01971554 | Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Participants With Type 2 Diabetes Mellitus (MK-8666-003) | PHASE1 | COMPLETED | 63 | — | — | Oct 14, 2013 | Apr 26, 2014 | Sep 10, 2018 | - | — |
Blood glucose was measured on a fasting basis (collected after an 8-hour fast). Blood was collected on Day -1 (pre-planned dose), predose on Days 1, 3, 7, and 14, and 24h postdose Day 14 (Day 15). The baseline measurement was computed as the average of the Day -1 and predose Day 1 measurements. FPG is expressed as mg/dL. This change from baseline reflects values for Day 15 FPG minus Day 0 FPG values.
An adverse event (AE) 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.
An adverse event (AE) 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.
| Arm | Type | Description |
|---|---|---|
| MK-8666 50 mg | EXPERIMENTAL | MK-8666, 50 mg, oral, once a day (QD) for Days 1 to 14. |
| MK-8666 150 mg | EXPERIMENTAL | MK-8666, 150 mg, oral, QD, for Days 1 to 14 |
| MK-8666 500 mg | EXPERIMENTAL | MK-8666, 500 mg, oral, QD for Days 1 to 14 |
| Placebo | PLACEBO_COMPARATOR | Placebo, oral, QD for Days 1 to 14 |
| Name | Type | Description |
|---|---|---|
| MK-8666 | DRUG | MK-8666, capsules, oral, QD, Days 1 to 14 |
| Placebo | DRUG | Placebo, capsules, oral, QD, Days 1 to 14 |
Inclusion Criteria: * If female, must be either postmenopausal or surgically sterile * A Body Mass Index (BMI) ≥18 kg/m\^2 to ≤40 kg/m\^2, inclusive. * A diagnosis of T2DM * Drug naïve or is being treated with no more than 2 oral antihyperglycemic agents (thiazolidenediones are excluded) * Judged t...