Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005) (NCT NCT02004886)
NCT ID: NCT02004886
Last Updated: 2018-09-05
Results Overview
Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2018-09-05
Participant Flow
A total of 13 clinical sites were used in this study in the following countries: Austria, Germany, New Zealand, Russia, and the United States of America.
Participant milestones
| Measure |
MK-0893 (40 mg)
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
Metformin, oral, 1000 mg, twice daily
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
18
|
19
|
|
Overall Study
COMPLETED
|
18
|
17
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
MK-0893 (40 mg)
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
Metformin, oral, 1000 mg, twice daily
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Unable to attend future visits
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)
Baseline characteristics by cohort
| Measure |
MK-0893 (40 mg)
n=19 Participants
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=18 Participants
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 Participants
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=19 Participants
Placebo
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.5 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
55.8 Years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
54.7 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
51.5 Years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
54.1 Years
STANDARD_DEVIATION 8.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.
Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period.
Outcome measures
| Measure |
MK-0893 (40 mg)
n=18 Participants
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=17 Participants
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 Participants
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
|
-37.9 mg/dL
Interval -47.1 to -28.8
|
-65.7 mg/dL
Interval -74.8 to -56.5
|
-38.1 mg/dL
Interval -47.0 to -29.2
|
-12.0 mg/dL
Interval -20.7 to -3.4
|
PRIMARY outcome
Timeframe: Up to 42 daysPopulation: Safety Population included all randomized participants who initiated study therapy.
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Outcome measures
| Measure |
MK-0893 (40 mg)
n=19 Participants
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=18 Participants
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 Participants
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
3 Number of Participants
|
7 Number of Participants
|
9 Number of Participants
|
8 Number of Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Safety Population included all randomized participants who initiated study therapy.
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Outcome measures
| Measure |
MK-0893 (40 mg)
n=19 Participants
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=18 Participants
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 Participants
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|---|---|
|
Number of Participants Discontinuing Study Treatment Due to an AE
|
0 Number of Participants
|
1 Number of Participants
|
0 Number of Participants
|
0 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.
Plasma Glucose levels were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Outcome measures
| Measure |
MK-0893 (40 mg)
n=18 Participants
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=17 Participants
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 Participants
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
|
-32.5 mg/dL
Interval -45.1 to -19.8
|
-57.7 mg/dL
Interval -70.3 to -45.1
|
-22.8 mg/dL
Interval -35.0 to -10.5
|
-14.1 mg/dL
Interval -26.1 to -2.2
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.
Fructosamine levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Outcome measures
| Measure |
MK-0893 (40 mg)
n=18 Participants
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=17 Participants
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 Participants
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in Fructosamine at Week 4
|
NA mg/dL
Data for this outcome measure were not collected or analyzed.
|
NA mg/dL
Data for this outcome measure were not collected or analyzed.
|
NA mg/dL
Data for this outcome measure were not collected or analyzed.
|
NA mg/dL
Data for this outcome measure were not collected or analyzed.
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.
Fasting C-peptide levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Outcome measures
| Measure |
MK-0893 (40 mg)
n=18 Participants
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=17 Participants
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 Participants
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide at Week 4
|
0.1 ng/mL
95% Confidence Interval 0.4 • Interval -0.5 to 0.7
|
-0.3 ng/mL
95% Confidence Interval 0.3 • Interval -0.8 to 0.3
|
-0.1 ng/mL
95% Confidence Interval 0.3 • Interval -0.6 to 0.5
|
-0.0 ng/mL
95% Confidence Interval 0.2 • Interval -0.6 to 0.5
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.
Fasting insulin levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Outcome measures
| Measure |
MK-0893 (40 mg)
n=18 Participants
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=17 Participants
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 Participants
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Insulin at Week 4
|
NA μIU/mL
Data for this outcome measure were not collected or analyzed.
|
NA μIU/mL
Data for this outcome measure were not collected or analyzed.
|
NA μIU/mL
Data for this outcome measure were not collected or analyzed.
|
NA μIU/mL
Data for this outcome measure were not collected or analyzed.
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.
2-hour post-prandial glucose excursion is the change in glucose concentration in the blood 2 hours after a meal. Change from baseline in 2-hour post-prandial glucose excursion at Week 4 is defined as Week 4 minus baseline.
Outcome measures
| Measure |
MK-0893 (40 mg)
n=18 Participants
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=17 Participants
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 Participants
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4
|
-10.5 mg/dL
Interval -20.2 to -0.8
|
-15.3 mg/dL
Interval -25.1 to -5.5
|
-29.0 mg/dL
Interval -38.4 to -19.5
|
-2.8 mg/dL
Interval -12.2 to 6.5
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.
Blood samples collected for glucose 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for Glucose was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Outcome measures
| Measure |
MK-0893 (40 mg)
n=18 Participants
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=17 Participants
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 Participants
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4
|
-128.8 mg hr/dL
Interval -169.5 to -88.2
|
-230.2 mg hr/dL
Interval -270.5 to -189.9
|
-136.7 mg hr/dL
Interval -175.7 to -97.6
|
-39.0 mg hr/dL
Interval -77.3 to -0.8
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.
Blood samples were collected for C-peptide 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for C-peptide was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Outcome measures
| Measure |
MK-0893 (40 mg)
n=18 Participants
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=16 Participants
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 Participants
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=18 Participants
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in 3-hour AUC for C-peptide at Week 4
|
1.0 ng hr/mL
Interval -0.9 to 2.9
|
-0.5 ng hr/mL
Interval -2.5 to 1.4
|
-0.2 ng hr/mL
Interval -2.1 to 1.6
|
-0.1 ng hr/mL
Interval -1.9 to 1.8
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.
Blood samples were collected for insulin 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour Insulin Total AUC was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.
Outcome measures
| Measure |
MK-0893 (40 mg)
n=17 Participants
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=15 Participants
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 Participants
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|---|---|
|
Change From Baseline in 3-hour Insulin Total AUC at Week 4
|
5.3 µIU hr/mL
Interval -15.5 to 26.1
|
6.1 µIU hr/mL
Interval -15.3 to 27.6
|
1.2 µIU hr/mL
Interval -18.4 to 20.7
|
7.8 µIU hr/mL
Interval -11.2 to 26.8
|
Adverse Events
MK-0893 (40 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-0893 (120 mg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Metformin (2000 mg)
Serious events: 0 serious events
Other events: 9 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
| Measure |
MK-0893 (40 mg)
n=19 participants at risk
MK-0893 40-mg, once daily
|
MK-0893 (120 mg)
n=18 participants at risk
MK-0893, 120 mg, once daily
|
Metformin (2000 mg)
n=18 participants at risk
Metformin, oral, 1000 mg, twice daily
|
Placebo
n=19 participants at risk
Placebo
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
External Ear Pain
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
11.1%
2/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
16.7%
3/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
10.5%
2/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Gastrointestinal disorders
Gingival Pain
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
10.5%
2/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
General disorders
Chest Discomfort
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
General disorders
Feeling Abnormal
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
General disorders
Nodule
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
General disorders
Thirst
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
11.1%
2/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
10.5%
2/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Infections and infestations
Viral Infection
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
11.1%
2/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
11.1%
2/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Reproductive system and breast disorders
Testicular Pain
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
5.3%
1/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
5.6%
1/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/18 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study drug.
|
0.00%
0/19 • Up to 42 days
Safety Population included all randomized participants who initiated study therapy. Adverse events were collected up to 14 days after last dose of study 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.
- Publication restrictions are in place
Restriction type: OTHER