A Phase 1 interventional study of MK-8655 and Placebo in Type 2 Diabetes, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-11-13.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
This study will assess the initial safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-8655, after single and multiple daily oral administrations to participants with Type 2 Diabetes (T2DM). The study will assess the reduction in fasting plasma glucose concentrations from baseline after multiple daily administrations of MK-8655.
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This study's enrollment of 33 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
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.
Drug: MK-8655
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.
Drug: Placebo
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.
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).
Number of Participants With One or More Adverse Events
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)
Number of Participants Discontinuing Study Drug Due to an Adverse Event
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
Fasting Plasma Glucose (FPG)
Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast.
Time frame: Day 16 (Predose)
True Geometric Mean Plasma Concentrations of MK-8655 After Single and Multiple Drug Doses at 24 Hours Post Dose (C24)
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
24-Hour Weighted Mean Glucose (WMG)
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.
Change From Baseline at 2 Hours Oral Glucose Tolerance Test
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
Participant was a male or female (of non-child bearing potential) between 18 to 65 years of age with a diagnosis of Type 2 diabetes mellitus (T2DM) and was either drug naïve or was being treated with metformin only.
| Milestone | MK-8655 80 mg/MK-8655 320 mg | Placebo |
|---|---|---|
| Started | 22 | 11 |
| Completed | 20 | 10 |
| Not completed | 2 | 1 |
| Withdrew: Protocol violation | 2 | 1 |
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.
| Participants | MK-8655 80 mg/MK-8655 320 mg | Placebo |
|---|---|---|
| Number of Participants With One or More Adverse Events | 11 | 7 |
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.
| Participants | MK-8655 80 mg/MK-8655 320 mg | Placebo |
|---|---|---|
| Number of Participants Discontinuing Study Drug Due to an Adverse Event | 0 | 0 |
Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast.
| mg/dL | MK-8655 80 mg/MK-8655 320 mg | Placebo |
|---|---|---|
| Fasting Plasma Glucose (FPG) | 195.5 ± 52.5 | 211.8 ± 70.2 |
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.
| uM | MK-8655 80 mg/MK-8655 320 mg | Placebo |
|---|---|---|
| Day 1, MK-8655 80 mg, single dose | 0.133 ± 68.2 | — |
| Day 1, MK-8655 320 mg, multiple doses | 0.477 ± 72.1 | — |
| Day 7, MK-8655 320 mg, multiple doses | 0.549 ± 66.9 | — |
| Day 14, MK-8655 320 mg, multiple doses | 0.612 ± 69.4 | — |
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.
| mg/dL | MK-8655 80 mg/MK-8655 320 mg | Placebo |
|---|---|---|
| 24-Hour Weighted Mean Glucose (WMG) | 205.5 ± 33.95 | 199.9 ± 78.81 |
Plasma glucose excursion was assessed during an oral glucose tolerance test (oGTT) following a single dose administration of MK-8655 in participants with T2DM.
| mg/dL | MK-8655 80 mg/MK-8655 320 mg | Placebo |
|---|---|---|
| Day 1 | 164.0 ± 41.4 | 134.7 ± 74.5 |
| Day 3 | 162.3 ± 37.0 | 135.0 ± 74.1 |
| Day 16 | 172.4 ± 39.2 | 156.1 ± 79.4 |
Collected over Up to 31 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MK-8655 80 mg/MK-8655 320 mg | 0/22 (0%) | 0/22 (0%) | 11/22 (50%) |
| Placebo | 0/11 (0%) | 0/11 (0%) | 7/11 (63.6%) |
| Event | MK-8655 80 mg/MK-8655 320 mg | Placebo |
|---|---|---|
| Viral upper respiratory tract infectionInfections and infestations | 4/22 | 3/11 |
| TirednessGeneral disorders | 1/22 | 1/11 |
| Upper respiratory tract infectionInfections and infestations | 1/22 | 1/11 |
| Ferritin decreasedInvestigations | 1/22 | 1/11 |
| Glucose increasedInvestigations | 2/22 | 1/11 |
| Hypoglycaemic reactionMetabolism and nutrition disorders | 0/22 | 1/11 |
| DizzinessNervous system disorders | 2/22 | 1/11 |
| HeadacheNervous system disorders | 1/22 | 1/11 |
| AnxietyPsychiatric disorders | 0/22 | 1/11 |
| Watering eyesEye disorders | 1/22 | 0/11 |
All randomized participants
| Age, Customized(Participants) | MK-8655 80 mg/MK-8655 320 mg | Placebo | Total |
|---|---|---|---|
| 31 to 63 years | 22 | 11 | 33 |
| Sex: Female, Male(Participants) | MK-8655 80 mg/MK-8655 320 mg | Placebo | Total |
|---|---|---|---|
| Female | 11 | 4 | 15 |
| Male | 11 | 7 | 18 |
No study locations are listed for this record.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC