Trial Outcomes & Findings for An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006) (NCT NCT00511472)
NCT ID: NCT00511472
Last Updated: 2015-07-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
70 participants
Primary outcome timeframe
39 days
Results posted on
2015-07-15
Participant Flow
Participant milestones
| Measure |
MK-0941
Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
|
Placebo
Participants receiving placebo while on basal insulin.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
23
|
|
Overall Study
COMPLETED
|
44
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
MK-0941
Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
|
Placebo
Participants receiving placebo while on basal insulin.
|
|---|---|---|
|
Overall Study
Clinical Adverse Event
|
1
|
2
|
|
Overall Study
Laboratory Adverse Event
|
0
|
2
|
|
Overall Study
Not reported
|
2
|
2
|
Baseline Characteristics
An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)
Baseline characteristics by cohort
| Measure |
MK-0941
n=47 Participants
Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
|
Placebo
n=23 Participants
Participants receiving placebo while on basal insulin.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<22 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Age, Customized
22 to 69 years
|
47 participants
n=93 Participants
|
23 participants
n=4 Participants
|
70 participants
n=27 Participants
|
|
Age, Customized
>69 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 39 daysPopulation: All participants who experienced one or more adverse events during the study
Outcome measures
| Measure |
MK-0941
n=47 Participants
Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
|
Placebo
n=23 Participants
Participants receiving placebo while on basal insulin.
|
Placebo
Participants receiving placebo while on basal insulin.
|
|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event During the Study
|
46 participants
|
21 participants
|
—
|
SECONDARY outcome
Timeframe: 25 daysPopulation: All participants who experienced one or more adverse events within 25 days of Titration Scheme 1
In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis in 10-mg q.a.c. increments on Titration Dose \[TD\] Days 1 to 4 of the Titration Phase 1 of the study.
Outcome measures
| Measure |
MK-0941
n=23 Participants
Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
|
Placebo
n=12 Participants
Participants receiving placebo while on basal insulin.
|
Placebo
Participants receiving placebo while on basal insulin.
|
|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event - Titration Scheme 1
|
20 participants
|
11 participants
|
—
|
SECONDARY outcome
Timeframe: 25 daysPopulation: All participants who experienced one or more adverse events within 25 days of Titration Scheme 2
Titration Scheme #2 (Titration Phase, Days 1 to 4) was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration.
Outcome measures
| Measure |
MK-0941
n=24 Participants
Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
|
Placebo
n=11 Participants
Participants receiving placebo while on basal insulin.
|
Placebo
Participants receiving placebo while on basal insulin.
|
|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event - Titration Scheme 2
|
22 participants
|
10 participants
|
—
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: All participants who had 24-hour weighted mean blood glucose levels evaluated on Day 7
Measurement of the 24-hour weighted mean blood glucose levels of participants receiving MK-0941 or placebo while on basal insulin on Day 7.
Outcome measures
| Measure |
MK-0941
n=22 Participants
Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
|
Placebo
n=24 Participants
Participants receiving placebo while on basal insulin.
|
Placebo
n=20 Participants
Participants receiving placebo while on basal insulin.
|
|---|---|---|---|
|
24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7
|
155.5 mg/dL
Standard Deviation 62.9
|
151.3 mg/dL
Standard Deviation 47.4
|
201.6 mg/dL
Standard Deviation 54.9
|
SECONDARY outcome
Timeframe: Outpatient Days 1 to 14Population: All participants who experienced one or more adverse events during the Outpatient Treatment Period.
During the Outpatient Treatment Period, participants were followed for an additional 2 weeks while at home.
Outcome measures
| Measure |
MK-0941
n=44 Participants
Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
|
Placebo
n=17 Participants
Participants receiving placebo while on basal insulin.
|
Placebo
Participants receiving placebo while on basal insulin.
|
|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period
|
20 participants
|
11 participants
|
—
|
Adverse Events
MK-0941 Titration 1
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
MK-0941 Titration 2
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo Titration 1
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo Titration 2
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-0941 Titration 1
n=23 participants at risk
Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 1 while on basal insulin.
|
MK-0941 Titration 2
n=24 participants at risk
Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 2 while on basal insulin.
|
Placebo Titration 1
n=12 participants at risk
Participants receiving placebo while on basal insulin.
|
Placebo Titration 2
n=11 participants at risk
Participants receiving placebo while on basal insulin.
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Multiple Injuries
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Injury, poisoning and procedural complications
Vaginal Haemorrhage
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
Other adverse events
| Measure |
MK-0941 Titration 1
n=23 participants at risk
Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 1 while on basal insulin.
|
MK-0941 Titration 2
n=24 participants at risk
Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 2 while on basal insulin.
|
Placebo Titration 1
n=12 participants at risk
Participants receiving placebo while on basal insulin.
|
Placebo Titration 2
n=11 participants at risk
Participants receiving placebo while on basal insulin.
|
|---|---|---|---|---|
|
Eye disorders
Dry Eye
|
4.3%
1/23 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
2/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
4.3%
1/23 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
2/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
18.2%
2/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
21.7%
5/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
3/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
16.7%
4/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
21.7%
5/23 • 25 days
All participants who received at least 1 dose of study drug
|
16.7%
4/24 • 25 days
All participants who received at least 1 dose of study drug
|
25.0%
3/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.7%
2/23 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
2/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
18.2%
2/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
43.5%
10/23 • 25 days
All participants who received at least 1 dose of study drug
|
29.2%
7/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
25.0%
3/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Dizziness
|
17.4%
4/23 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
2/24 • 25 days
All participants who received at least 1 dose of study drug
|
16.7%
2/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Headache
|
39.1%
9/23 • 25 days
All participants who received at least 1 dose of study drug
|
41.7%
10/24 • 25 days
All participants who received at least 1 dose of study drug
|
41.7%
5/12 • 25 days
All participants who received at least 1 dose of study drug
|
54.5%
6/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
16.7%
2/12 • 25 days
All participants who received at least 1 dose of study drug
|
18.2%
2/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Tremor
|
17.4%
4/23 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
2/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
18.2%
2/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.7%
2/23 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
2/24 • 25 days
All participants who received at least 1 dose of study drug
|
16.7%
2/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Eye disorders
Vision Blurred
|
4.3%
1/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Dry Mouth
|
8.7%
2/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Toothache
|
8.7%
2/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
General disorders
Asthenia
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
2/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
General disorders
Fatigue
|
4.3%
1/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
General disorders
Pain
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
General disorders
Vessel Puncture Site Pain
|
4.3%
1/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Infections and infestations
Cellulitis
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Infections and infestations
Influenza
|
4.3%
1/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Infections and infestations
Urinary Tract Infection
|
4.3%
1/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
2/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
1/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
2/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Nervous system disorders
Somnolence
|
4.3%
1/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
2/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Renal and urinary disorders
Polyuria
|
4.3%
1/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
4.2%
1/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/12 • 25 days
All participants who received at least 1 dose of study drug
|
9.1%
1/11 • 25 days
All participants who received at least 1 dose of study drug
|
|
Vascular disorders
Peripheral Coldness
|
0.00%
0/23 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/24 • 25 days
All participants who received at least 1 dose of study drug
|
8.3%
1/12 • 25 days
All participants who received at least 1 dose of study drug
|
0.00%
0/11 • 25 days
All participants who received at least 1 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. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER