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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01640873 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002) | PHASE1 | COMPLETED | 33 | — | — | Sep 19, 2012 | Dec 20, 2012 | Nov 13, 2018 | - | — |
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.
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.
Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast.
| Arm | Type | Description |
|---|---|---|
| MK-8655 80 mg/MK-8655 320 mg | EXPERIMENTAL | Participants received a single dose of MK-8655, 80 mg on Day 1 and then MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days. |
| Placebo | PLACEBO_COMPARATOR | Participants received a single dose of placebo to MK-8655, 80 mg on Day 1 and then placebo to MK-8655 320 mg, once daily, starting on Day 3 for 14 consecutive days. |
| Name | Type | Description |
|---|---|---|
| MK-8655 | DRUG | Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies. |
| Placebo | DRUG | Participants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16). |
Inclusion Criteria: * Male or female of non-child bearing potential * Body Mass Index ≤40 kg/m\^2 * Diagnosis of Type 2 Diabetes (T2DM) and is either drug naive or is being treated with metformin only * In good health except for T2DM * Willing to follow a standard diet * Nonsmoker and/or no use of ...