Trial Outcomes & Findings for Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012) (NCT NCT00972322)

Results Overview

The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

56 participants

Primary outcome timeframe

Baseline and Day 28

Results posted on

2018-09-10

Participant Flow

This was a multicenter study in 5 clinical centers in the United States.

Participant milestones

Participant milestones
Measure	MK-8245 100 mg MK-8245, 50 mg, twice daily for 28 days	Placebo Placebo to MK-8245, twice daily for 28 days
Overall Study STARTED	28	28
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-8245 100 mg MK-8245, 50 mg, twice daily for 28 days	Placebo Placebo to MK-8245, twice daily for 28 days
Overall Study Adverse Event	2	1
Overall Study Positive drug screen	0	1
Overall Study Lost to Follow-up	0	1
Overall Study Consistently high glucose values	1	0

Baseline Characteristics

Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-8245 100 mg n=28 Participants MK-8245, 50 mg, twice daily for 28 days	Placebo n=28 Participants Placebo to MK-8245, twice daily for 28 days	Total n=56 Participants Total of all reporting groups
Age, Continuous	54.7 Years STANDARD_DEVIATION 8.53 • n=5 Participants	52.7 Years STANDARD_DEVIATION 7.30 • n=7 Participants	53.7 Years STANDARD_DEVIATION 7.93 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 28

Population: All participants who were compliant with the study procedures and have available data from at least one treatment were included in the primary analysis dataset.

The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose.

Outcome measures

Outcome measures
Measure	MK-8245 100 mg n=25 Participants MK-8245, 50 mg, twice daily for 28 days	Placebo n=26 Participants Placebo to MK-8245, twice daily for 28 days
Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)	11.0 mg/dL Standard Deviation 27.6	-4.4 mg/dL Standard Deviation 31.7

PRIMARY outcome

Timeframe: Up to Day 31

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

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. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	MK-8245 100 mg n=28 Participants MK-8245, 50 mg, twice daily for 28 days	Placebo n=28 Participants Placebo to MK-8245, twice daily for 28 days
Number of Participants Who Experienced Serious or Non-serious Adverse Events Serious Adverse Events	0 Participants	0 Participants
Number of Participants Who Experienced Serious or Non-serious Adverse Events Non-Serious Adverse Events	16 Participants	10 Participants

PRIMARY outcome

Timeframe: Up to Day 28

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

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.

Outcome measures

Outcome measures
Measure	MK-8245 100 mg n=28 Participants MK-8245, 50 mg, twice daily for 28 days	Placebo n=28 Participants Placebo to MK-8245, twice daily for 28 days
Number of Participants Discontinuing Study Drug Due to an AE	2 Participants	1 Participants

Adverse Events

MK-8245 100 mg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MK-8245 100 mg n=28 participants at risk MK-8245, 50 mg, twice daily for 28 days	Placebo n=28 participants at risk Placebo to MK-8245, twice daily for 28 days
Metabolism and nutrition disorders Decreased Appetite	7.1% 2/28 • Up to Day 31 All participants who received at least one dose of the investigational drug.	0.00% 0/28 • Up to Day 31 All participants who received at least one dose of the investigational drug.
Gastrointestinal disorders Constipation	3.6% 1/28 • Up to Day 31 All participants who received at least one dose of the investigational drug.	7.1% 2/28 • Up to Day 31 All participants who received at least one dose of the investigational drug.
Gastrointestinal disorders Diarrhoea	10.7% 3/28 • Up to Day 31 All participants who received at least one dose of the investigational drug.	0.00% 0/28 • Up to Day 31 All participants who received at least one dose of the investigational drug.
Infections and infestations Upper Respiratory Tract Infection	14.3% 4/28 • Up to Day 31 All participants who received at least one dose of the investigational drug.	3.6% 1/28 • Up to Day 31 All participants who received at least one dose of the investigational drug.
Nervous system disorders Headache	17.9% 5/28 • Up to Day 31 All participants who received at least one dose of the investigational drug.	10.7% 3/28 • Up to Day 31 All participants who received at least one dose of the investigational drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	7.1% 2/28 • Up to Day 31 All participants who received at least one dose of the investigational drug.	7.1% 2/28 • Up to Day 31 All participants who received at least one dose of the investigational drug.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER