Trial Outcomes & Findings for A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009) (NCT NCT00868790)
NCT ID: NCT00868790
Last Updated: 2018-09-10
Results Overview
The primary efficacy outcome in this study was the assessment of 24-hour weighted mean glucose (WMG) levels for domiciled participants after 4-week treatment (Periods 1 and 2 only). At selected study sites, a subset of participants domiciled (stayed) overnight and underwent 24-hour blood sampling at the Week 0 Visit (Baseline), Week 4 Visit (end of Period 1), and Week 8 Visit (end of Period 2). Domiciled participants were not expected to follow a weight-maintaining diet while receiving standard meals from a dietician or licensed healthcare professional. WMG was calculated as the weighted average value of the glucose from the 24-hour blood sample (for Baseline, Week 4, and Week 8) and analyzed using a Longitudinal Data Analysis (LDA) model. Results were expressed as the change from baseline after 4-week treatment in 24-hour WMG.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit
Results posted on
2018-09-10
Participant Flow
A total of 118 participants were randomized to one of 14 treatment sequence arms on this cross-over study. Each participant received 4 out of 5 treatments over 4 treatment periods. Before randomization, participants who had prior antihyperglycemic agent (AHA) treatment had a 4-week AHA wash-off, and all participants had a 2-week placebo run-in.
Participant milestones
| Measure |
PLA→MK-3577 QD AM→MK-3577 QD PM→MK-3577 BID (Arm 1)
Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
|
MK-3577 QD AM→PLA→MK-3577 BID→MK-3577 QD PM (Arm 2)
Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
|
MK-3577 QD PM→MK-3577 BID→PLA→MK-3577 QD AM (Arm 3)
Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed MK- 3577 25 mg BID for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
|
MK-3577 BID→MK-3577 QD PM→MK-3577 QD AM→PLA (Arm 4)
Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
|
PLA→MK-3577 BID→MK-3577 QD AM→MK-3577 QD PM (Arm 5)
Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
|
MK-3577 QD AM→MK-3577 QD PM→PLA→MK-3577 BID (Arm 6)
Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4.
|
MK-3577 QD PM→MK-3577 QD AM→MK-3577 BID→PLA (Arm 7)
Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
|
MK-3577 BID→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 8)
Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
|
PLA→MK-3577 QD PM→MK-3577 BID→MK-3577 QD AM (Arm 9)
Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
|
MK-3577 QD AM→MK-3577 BID→MK-3577 QD PM→PLA (Arm 10)
Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
|
MK-3577 QD PM→PLA→MK-3577 QD AM→MK-3577 BID (Arm 11)
Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
|
MK-3577 BID→MK-3577 QD AM→PLA→MK-3577 QD PM (Arm 12)
Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
|
PLA→METF→MK-3577 QD AM→MK-3577 QD PM (Arm 13)
Domiciled participants received oral treatment with dose-matched placebo to metformin (METF) for 4 weeks during Period 1, followed by metformin 1000 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Participants in this arm were administered metformin placebo during Period 1 and active metformin during Period 2.
|
METF→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 14)
Domiciled participants received oral treatment with metformin 1000 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to metformin for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4. Participants in this arm were administered active metformin during Period 1 and metformin placebo during Period 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
11
|
8
|
4
|
4
|
19
|
3
|
4
|
20
|
11
|
3
|
9
|
4
|
7
|
11
|
|
Period 1
COMPLETED
|
9
|
7
|
4
|
4
|
18
|
2
|
4
|
17
|
10
|
3
|
9
|
4
|
7
|
9
|
|
Period 1
NOT COMPLETED
|
2
|
1
|
0
|
0
|
1
|
1
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
2
|
|
Period 2
STARTED
|
9
|
7
|
4
|
4
|
18
|
2
|
4
|
17
|
10
|
3
|
9
|
4
|
7
|
9
|
|
Period 2
COMPLETED
|
9
|
6
|
4
|
4
|
18
|
1
|
4
|
17
|
8
|
3
|
9
|
4
|
7
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
1
|
|
Period 3
STARTED
|
9
|
6
|
4
|
4
|
18
|
1
|
4
|
17
|
8
|
3
|
9
|
4
|
7
|
8
|
|
Period 3
COMPLETED
|
9
|
6
|
4
|
3
|
18
|
1
|
4
|
17
|
8
|
2
|
8
|
4
|
7
|
8
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Period 4
STARTED
|
9
|
6
|
4
|
3
|
18
|
1
|
4
|
17
|
8
|
2
|
8
|
4
|
7
|
8
|
|
Period 4
COMPLETED
|
7
|
6
|
3
|
3
|
18
|
1
|
4
|
14
|
6
|
2
|
5
|
3
|
6
|
7
|
|
Period 4
NOT COMPLETED
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
3
|
2
|
0
|
3
|
1
|
1
|
1
|
|
Post-study
STARTED
|
7
|
6
|
3
|
3
|
18
|
1
|
4
|
14
|
6
|
2
|
5
|
3
|
6
|
7
|
|
Post-study
COMPLETED
|
7
|
6
|
3
|
3
|
17
|
1
|
4
|
12
|
6
|
1
|
5
|
3
|
6
|
7
|
|
Post-study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
PLA→MK-3577 QD AM→MK-3577 QD PM→MK-3577 BID (Arm 1)
Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
|
MK-3577 QD AM→PLA→MK-3577 BID→MK-3577 QD PM (Arm 2)
Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
|
MK-3577 QD PM→MK-3577 BID→PLA→MK-3577 QD AM (Arm 3)
Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed MK- 3577 25 mg BID for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
|
MK-3577 BID→MK-3577 QD PM→MK-3577 QD AM→PLA (Arm 4)
Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
|
PLA→MK-3577 BID→MK-3577 QD AM→MK-3577 QD PM (Arm 5)
Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
|
MK-3577 QD AM→MK-3577 QD PM→PLA→MK-3577 BID (Arm 6)
Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4.
|
MK-3577 QD PM→MK-3577 QD AM→MK-3577 BID→PLA (Arm 7)
Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
|
MK-3577 BID→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 8)
Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
|
PLA→MK-3577 QD PM→MK-3577 BID→MK-3577 QD AM (Arm 9)
Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
|
MK-3577 QD AM→MK-3577 BID→MK-3577 QD PM→PLA (Arm 10)
Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
|
MK-3577 QD PM→PLA→MK-3577 QD AM→MK-3577 BID (Arm 11)
Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
|
MK-3577 BID→MK-3577 QD AM→PLA→MK-3577 QD PM (Arm 12)
Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
|
PLA→METF→MK-3577 QD AM→MK-3577 QD PM (Arm 13)
Domiciled participants received oral treatment with dose-matched placebo to metformin (METF) for 4 weeks during Period 1, followed by metformin 1000 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Participants in this arm were administered metformin placebo during Period 1 and active metformin during Period 2.
|
METF→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 14)
Domiciled participants received oral treatment with metformin 1000 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to metformin for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4. Participants in this arm were administered active metformin during Period 1 and metformin placebo during Period 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Period 1
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 1
Abnormal Triglycerides
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Period 3
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 3
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 3
Study Terminated by Sponsor
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 4
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Period 4
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 4
Study Terminated by Sponsor
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
2
|
1
|
0
|
1
|
|
Period 4
Abnormal ALT/AST
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Post-study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Post-study
Excluded Medication
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009)
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=118 Participants
All randomized participants who took at least one dose of study treatment
|
|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Week 0 Visit (Baseline), Week 4 Visit, Week 8 VisitPopulation: All randomized domiciled participants receiving ≥1 dose of therapy and having 24-hour WMG measurement either at BL or end of Treatment Period 1 or 2. Number of Participants Analyzed=number of participants included in LDA model. Participants in MK-3577 25 mg BID group did not undergo 24-hour glucose sampling and were not analyzed.
The primary efficacy outcome in this study was the assessment of 24-hour weighted mean glucose (WMG) levels for domiciled participants after 4-week treatment (Periods 1 and 2 only). At selected study sites, a subset of participants domiciled (stayed) overnight and underwent 24-hour blood sampling at the Week 0 Visit (Baseline), Week 4 Visit (end of Period 1), and Week 8 Visit (end of Period 2). Domiciled participants were not expected to follow a weight-maintaining diet while receiving standard meals from a dietician or licensed healthcare professional. WMG was calculated as the weighted average value of the glucose from the 24-hour blood sample (for Baseline, Week 4, and Week 8) and analyzed using a Longitudinal Data Analysis (LDA) model. Results were expressed as the change from baseline after 4-week treatment in 24-hour WMG.
Outcome measures
| Measure |
Placebo (PLA)
n=38 Participants
Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
|
MK-3577 AM
n=10 Participants
Domiciled participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks
|
MK-3577 PM
n=11 Participants
Domiciled participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
|
MK-3577 BID
Domiciled participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
|
METF BID
n=15 Participants
Domiciled participants received metformin 1000 mg orally BID 4 weeks (received during Period 1 or 2 only).
|
|---|---|---|---|---|---|
|
Change From Baseline (BL) After 4-Week Treatment in Weighted Mean Glucose (WMG)
|
-1.6 mg/dL
Standard Error 4.1
|
-18.8 mg/dL
Standard Error 6.8
|
-25.0 mg/dL
Standard Error 6.7
|
—
|
-36.5 mg/dL
Standard Error 6.1
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).Population: All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Outcome measures
| Measure |
Placebo (PLA)
n=108 Participants
Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
|
MK-3577 AM
n=106 Participants
Domiciled participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks
|
MK-3577 PM
n=105 Participants
Domiciled participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
|
MK-3577 BID
n=89 Participants
Domiciled participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
|
METF BID
n=18 Participants
Domiciled participants received metformin 1000 mg orally BID 4 weeks (received during Period 1 or 2 only).
|
|---|---|---|---|---|---|
|
Number of Participants With At Least One Adverse Event (AE) in the Treatment or Post-Treatment Periods
|
28 Participants
|
30 Participants
|
22 Participants
|
28 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Week 0 Visit) to Week 16 Visit (up to 16 weeks).Population: All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Outcome measures
| Measure |
Placebo (PLA)
n=108 Participants
Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
|
MK-3577 AM
n=106 Participants
Domiciled participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks
|
MK-3577 PM
n=105 Participants
Domiciled participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
|
MK-3577 BID
n=89 Participants
Domiciled participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
|
METF BID
n=18 Participants
Domiciled participants received metformin 1000 mg orally BID 4 weeks (received during Period 1 or 2 only).
|
|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 VisitPopulation: All randomized participants receiving ≥1 dose of therapy and having FPG measurement either at BL or end of Treatment Period. Number of Participants Analyzed=number of participants included in the LDA model.
Fasting blood samples were obtained during study site visits at Baseline (Week 0 Visit) and Week 4 of each treatment period (Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit). Participants were counseled to fast (no food or drink except water and non-study medications, as directed) for at least 12 hours prior to all study visits. FPG was analyzed using an LDA model, and change from baseline (Week 0) after 4-week treatment in FPG was reported.
Outcome measures
| Measure |
Placebo (PLA)
n=104 Participants
Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
|
MK-3577 AM
n=100 Participants
Domiciled participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks
|
MK-3577 PM
n=98 Participants
Domiciled participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
|
MK-3577 BID
n=86 Participants
Domiciled participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
|
METF BID
n=18 Participants
Domiciled participants received metformin 1000 mg orally BID 4 weeks (received during Period 1 or 2 only).
|
|---|---|---|---|---|---|
|
Change From Baseline (BL) After 4-Week Treatment in Fasting Plasma Glucose (FPG)
|
4.3 mg/dL
Standard Error 3.8 • Interval -17.5 to -5.4
|
-7.2 mg/dL
Standard Error 3.5 • Interval -27.8 to -15.8
|
-17.5 mg/dL
Standard Error 3.5 • Interval -42.0 to -30.0
|
-31.7 mg/dL
Standard Error 3.5 • Interval -30.0 to -10.1
|
-14.4 mg/dL
Standard Error 6.2
|
SECONDARY outcome
Timeframe: Week 0 Visit (Baseline), Week 4 Visit, Week 8 visitPopulation: All randomized participants receiving ≥1 dose of therapy and having MTT measurement either at Week 0 (BL) or end of Treatment Period 1. N=number of participants included in the Longitudinal Data Analysis (LDA) model
Two-hour PMG was analyzed in both non-domiciled and domiciled participants. Non-domiciled participants completed a 3-point meal tolerance test (MTT) at Week 0 (Baseline) and Week 4 Visits of Treatment Period 1. Participants completed 12-hr fasting prior to the Week 0 (Baseline) and Week-4 clinic visits. Fasting blood samples were obtained at the beginning of these clinic visits, after which participants consumed a standardized meal (1 nutrition bar and 1 can of nutrition drink), and then completed the MTT, in which plasma glucose was measured at 30 min and 120 min (2 hr) post-meal. The 2-hr PMG data also include data from domiciled participants, based on 2-hr post-morning meal glucose levels in the 24-hr blood glucose sample at the Week 4 and Week 8 Visits. The 2-hour PMG was analyzed using an LDA model, and change from baseline (Week 0) after 4-week treatment in 2-hour PMG was reported.
Outcome measures
| Measure |
Placebo (PLA)
n=59 Participants
Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
|
MK-3577 AM
n=17 Participants
Domiciled participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks
|
MK-3577 PM
n=19 Participants
Domiciled participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
|
MK-3577 BID
n=21 Participants
Domiciled participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
|
METF BID
n=15 Participants
Domiciled participants received metformin 1000 mg orally BID 4 weeks (received during Period 1 or 2 only).
|
|---|---|---|---|---|---|
|
Change From BL After 4-Week Treatment in 2-hour Post-Meal Glucose (PMG) Levels
|
-5.2 mg/dL
Standard Error 5.9
|
-20.1 mg/dL
Standard Error 10.3
|
-25.6 mg/dL
Standard Error 10.2
|
-73.0 mg/dL
Standard Error 9.3
|
-54.6 mg/dL
Standard Error 10.3
|
SECONDARY outcome
Timeframe: Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 VisitPopulation: All randomized participants who took at least 1 dose of study treatment and had a valid reading at timepoint.
Blood samples were obtained from all participants to measure LDL-C levels at Week 0 (Baseline) and Week 4 of each treatment period (Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit). For each visit, LDL-C was measured over 2 days. The average of duplicate measurements (when available) was used in the analysis.
Outcome measures
| Measure |
Placebo (PLA)
n=102 Participants
Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
|
MK-3577 AM
n=100 Participants
Domiciled participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks
|
MK-3577 PM
n=99 Participants
Domiciled participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
|
MK-3577 BID
n=86 Participants
Domiciled participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
|
METF BID
n=18 Participants
Domiciled participants received metformin 1000 mg orally BID 4 weeks (received during Period 1 or 2 only).
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline (BL) After 4-Week Treatment in Low-Density Lipoprotein C (LDL-C) Levels
|
2.3 percentage change from BL
90% Confidence Interval 25.0 • Interval -1.6 to 6.3
|
1.5 percentage change from BL
90% Confidence Interval 27.9 • Interval -2.0 to 5.1
|
6.8 percentage change from BL
90% Confidence Interval 27.9 • Interval 3.1 to 10.6
|
10.0 percentage change from BL
90% Confidence Interval 21.8 • Interval 6.3 to 13.9
|
-1.7 percentage change from BL
90% Confidence Interval 23.4 • Interval -7.7 to 4.8
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-3577 AM
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-3577 PM
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-3577 BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
METF BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=108 participants at risk
Participants received a placebo tablet matching the respective MK-3577 dose (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
|
MK-3577 AM
n=106 participants at risk
Participants received 10 mg MK-3577 orally QD in the AM for 4 weeks.
|
MK-3577 PM
n=105 participants at risk
Participants received 6 mg MK-3577 orally QD in the PM for 4 weeks.
|
MK-3577 BID
n=89 participants at risk
Participants received 25 mg MK-3577 orally BID for 4 weeks.
|
METF BID
n=18 participants at risk
Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
|
|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/108 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/106 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.95%
1/105 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/89 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/18 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/108 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/106 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.95%
1/105 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/89 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/18 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
Infections and infestations
Cellulitis
|
0.93%
1/108 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/106 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/105 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/89 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/18 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/108 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.94%
1/106 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/105 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/89 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/18 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/108 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.94%
1/106 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/105 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/89 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/18 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
Other adverse events
| Measure |
Placebo
n=108 participants at risk
Participants received a placebo tablet matching the respective MK-3577 dose (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
|
MK-3577 AM
n=106 participants at risk
Participants received 10 mg MK-3577 orally QD in the AM for 4 weeks.
|
MK-3577 PM
n=105 participants at risk
Participants received 6 mg MK-3577 orally QD in the PM for 4 weeks.
|
MK-3577 BID
n=89 participants at risk
Participants received 25 mg MK-3577 orally BID for 4 weeks.
|
METF BID
n=18 participants at risk
Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
1/108 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.94%
1/106 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.95%
1/105 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
3.4%
3/89 • Number of events 3 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
5.6%
1/18 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
General disorders
Pyrexia
|
0.00%
0/108 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
1.9%
2/106 • Number of events 2 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.95%
1/105 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
1.1%
1/89 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
5.6%
1/18 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.93%
1/108 • Number of events 2 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/106 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/105 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/89 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
5.6%
1/18 • Number of events 2 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
Investigations
Heart rate increased
|
0.00%
0/108 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/106 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/105 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/89 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
5.6%
1/18 • Number of events 2 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/108 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/106 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/105 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/89 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
5.6%
1/18 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/108 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.94%
1/106 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/105 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
1.1%
1/89 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
5.6%
1/18 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
Nervous system disorders
Headache
|
0.93%
1/108 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.94%
1/106 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/105 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/89 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
5.6%
1/18 • Number of events 2 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/108 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/106 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/105 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/89 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
5.6%
1/18 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/108 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/106 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/105 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/89 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
5.6%
1/18 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
|
Vascular disorders
Hypertension
|
0.00%
0/108 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.00%
0/106 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
0.95%
1/105 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
1.1%
1/89 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
5.6%
1/18 • Number of events 1 • From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).
All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.
|
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR has 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. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER