Trial Outcomes & Findings for Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002) (NCT NCT03095651)
NCT ID: NCT03095651
Last Updated: 2019-04-01
Results Overview
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Up to 33 days
Results posted on
2019-04-01
Participant Flow
No participants were randomized to the T1DM (Type 1 Diabetes Mellitus) MK-5160 64 nmol/kg arm or the T2DM (Type 2 Diabetes Mellitus) MK-5160 16 nmol/kg arm.
Participant milestones
| Measure |
T1DM MK-5160 16 Nmol/kg
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
0
|
4
|
0
|
7
|
6
|
4
|
|
Overall Study
COMPLETED
|
5
|
5
|
0
|
3
|
0
|
6
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
T1DM MK-5160 16 Nmol/kg
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002)
Baseline characteristics by cohort
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
n=4 Participants
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=7 Participants
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
n=4 Participants
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Between 18 and 64 years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
32 Participants
n=114 Participants
|
|
Age, Customized
From 65 to 84 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
27 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
32 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Up to 33 daysPopulation: All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
n=4 Participants
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=7 Participants
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
n=4 Participants
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
6 Participants
|
6 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 12 daysPopulation: All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
n=4 Participants
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=7 Participants
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
n=4 Participants
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Discontinuing Study Drug Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours post-dose on Day 12Population: All participants that received study drug, had no major protocol violations, and had GIRmax values available on Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
Maximal glucose infusion rate required to maintain target glucose levels in a euglycemic clamp setting (GIRmax) at steady state (Day 12) following administration of study drug. In cases where the lower bound of the CI was negative, the lower confidence limit was truncated at zero. In these cases, the confidence intervals are 97.5% CIs.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
n=4 Participants
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
n=4 Participants
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Maximal Glucose Infusion Rate
|
2.15 mg/kg/min
Interval 1.04 to 3.25
|
2.86 mg/kg/min
Interval 1.8 to 3.92
|
—
|
2.56 mg/kg/min
Interval 1.26 to 3.86
|
—
|
1.98 mg/kg/min
Interval 1.03 to 2.93
|
2.15 mg/kg/min
Interval 1.15 to 3.14
|
3.25 mg/kg/min
Interval 2.03 to 4.47
|
SECONDARY outcome
Timeframe: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours following start of injection (FSOI). Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.Population: All participants that received MK-5160, had no major protocol violations, and had Cmax values available on Day 1 and Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg or T2DM MK-5160 16 nmol/kg arms. One participant in the T2DM MK-5160 32 nmol/kg arm withdrew consent after receiving a single dose of study drug.
Cmax of MK-5160 following multiple dose administration of study drug. Glargine data are presented in the following outcome measure.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=7 Participants
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MK-5160
Day 1
|
0.76 nM
Interval 0.59 to 0.97
|
1.58 nM
Interval 0.99 to 2.53
|
—
|
—
|
—
|
1.33 nM
Interval 0.97 to 1.82
|
1.91 nM
Interval 1.22 to 2.99
|
—
|
|
Maximum Plasma Concentration (Cmax) of MK-5160
Day 12
|
2.33 nM
Interval 1.75 to 3.1
|
5.38 nM
Interval 3.33 to 8.69
|
—
|
—
|
—
|
3.85 nM
Interval 2.94 to 5.05
|
9.03 nM
Interval 7.73 to 10.55
|
—
|
SECONDARY outcome
Timeframe: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.Population: All participants that received glargine, had no major protocol violations, and had Cmax values available on Day 1 and Day 12.
Cmax of glargine following multiple dose administration of study drug. MK-5160 data are presented in the preceding outcome measure.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
n=4 Participants
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
n=4 Participants
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Glargine
Day 1
|
—
|
—
|
—
|
17.26 pmol/L
Interval 13.12 to 22.7
|
—
|
—
|
—
|
18.97 pmol/L
Interval 5.29 to 68.0
|
|
Maximum Plasma Concentration (Cmax) of Glargine
Day 12
|
—
|
—
|
—
|
20.28 pmol/L
Interval 10.74 to 38.28
|
—
|
—
|
—
|
34.18 pmol/L
Interval 12.73 to 91.76
|
SECONDARY outcome
Timeframe: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.Population: Participants with Cmax measurements on Day 1 and Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
Day 12 to Day 1 accumulation ratio (AR) of Cmax of MK-5160 and glargine following multiple dose administration of study drug. Geometric mean accumulation ratio = Day 12 Cmax/Day 1 Cmax.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
n=4 Participants
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=7 Participants
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
n=4 Participants
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Day 12 to Day 1 Accumulation Ratio of Cmax
|
3.08 Ratio
Interval 2.37 to 4.0
|
3.40 Ratio
Interval 2.11 to 5.48
|
—
|
1.17 Ratio
Interval 0.8 to 1.74
|
—
|
2.89 Ratio
Interval 2.13 to 3.93
|
4.72 Ratio
Interval 3.46 to 6.44
|
1.80 Ratio
Interval 0.65 to 5.01
|
SECONDARY outcome
Timeframe: Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.Population: All participants that received MK-5160, had no major protocol violations, and had Css values available on Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
Css of MK-5160 is the amount of MK-5160 in a given volume of plasma at the time a "steady state" has been achieved, and rates of MK-5160 administration and MK-5160 elimination are equal. Glargine data are presented in the following outcome measure.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Steady State Plasma Concentration (Css) of MK-5160
|
1.79 nM
Interval 1.32 to 2.42
|
4.40 nM
Interval 2.55 to 7.57
|
—
|
—
|
—
|
2.64 nM
Interval 1.95 to 3.56
|
6.15 nM
Interval 5.73 to 6.61
|
—
|
SECONDARY outcome
Timeframe: Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.Population: All participants that received glargine, had no major protocol violations, and had Css values available on Day 12.
Css of glargine is the amount of glargine in a given volume of plasma at the time a "steady state" has been achieved, and rates of glargine administration and glargine elimination are equal. MK-5160 data are presented in the preceding outcome measure.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
n=4 Participants
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
n=4 Participants
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Steady State Plasma Concentration (Css) of Glargine
|
—
|
—
|
—
|
9.99 pmol/L
Interval 3.32 to 30.12
|
—
|
—
|
—
|
14.72 pmol/L
Interval 3.45 to 62.74
|
SECONDARY outcome
Timeframe: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI.Population: All participants that received MK-5160, had no major protocol violations, and had AUC0-24 values available on Day 1 and Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg or T2DM MK-5160 16 nmol/kg arms. One participant in the T2DM MK-5160 32 nmol/kg arm withdrew consent after receiving a single dose of study drug.
Area Under the Plasma Concentration/Time Curve for MK-5160 from Time 0 to 24 hours (AUC0-24) is a measure of the total amount of MK-5160 in the plasma from the dose administration to 24 hours. Glargine data are presented in the following outcome measure.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=7 Participants
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration/Time (AUC0-24) of MK-5160
Day 1
|
9.79 hr*nM
Interval 7.8 to 12.29
|
26.39 hr*nM
Interval 15.21 to 45.76
|
—
|
—
|
—
|
17.44 hr*nM
Interval 10.88 to 27.94
|
25.32 hr*nM
Interval 16.61 to 38.59
|
—
|
|
Plasma Concentration/Time (AUC0-24) of MK-5160
Day 12
|
42.90 hr*nM
Interval 31.64 to 58.17
|
105.5 hr*nM
Interval 61.3 to 181.7
|
—
|
—
|
—
|
63.29 hr*nM
Interval 46.83 to 85.52
|
147.7 hr*nM
Interval 137.5 to 158.6
|
—
|
SECONDARY outcome
Timeframe: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI.Population: All participants that received glargine, had no major protocol violations, and had AUC0-24 values available on Day 1 and Day 12.
AUC0-24 is a measure of the total amount of glargine in the plasma from the dose administration to 24 hours. MK-5160 data are presented in the preceding outcome measure.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
n=4 Participants
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
n=4 Participants
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration/Time (AUC0-24) of Glargine
Day 1
|
—
|
—
|
—
|
193.6 hr*pmol/L
Interval 96.81 to 387.2
|
—
|
—
|
—
|
149.6 hr*pmol/L
Interval 13.94 to 1605.0
|
|
Plasma Concentration/Time (AUC0-24) of Glargine
Day 12
|
—
|
—
|
—
|
239.8 hr*pmol/L
Interval 79.57 to 722.9
|
—
|
—
|
—
|
353.3 hr*pmol/L
Interval 82.9 to 1506.0
|
SECONDARY outcome
Timeframe: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI.Population: Participants with AUC0-24 measurements on Day 1 and Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
Day 12 to Day 1 Accumulation Ratio (AR) of the AUC0-24 of study drug (MK-5160 or glargine). Geometric mean accumulation ratio = Day 12 AUC0-24/Day 1 AUC0-24
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
n=4 Participants
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=7 Participants
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
n=4 Participants
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Day 12 to Day 1 Accumulation Ratio of AUC0-24.
|
4.38 Ratio
Interval 3.34 to 5.74
|
4.00 Ratio
Interval 2.3 to 6.94
|
—
|
1.24 Ratio
Interval 0.77 to 1.99
|
—
|
3.63 Ratio
Interval 2.37 to 5.56
|
5.83 Ratio
Interval 4.3 to 7.91
|
2.36 Ratio
Interval 0.41 to 13.74
|
SECONDARY outcome
Timeframe: Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.Population: All participants that received study drug, had no major protocol violations, and had CL values available on Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
Plasma Clearance (CL) of study drug is the volume of plasma cleared of study drug per unit time.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
n=4 Participants
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
n=4 Participants
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Plasma Clearance
|
0.37 L/hr/kg
Interval 0.28 to 0.51
|
0.30 L/hr/kg
Interval 0.18 to 0.52
|
—
|
10.01 L/hr/kg
Interval 3.32 to 30.16
|
—
|
0.51 L/hr/kg
Interval 0.37 to 0.68
|
0.43 L/hr/kg
Interval 0.4 to 0.47
|
10.19 L/hr/kg
Interval 2.39 to 43.43
|
SECONDARY outcome
Timeframe: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.Population: All participants that received study drug, had no major protocol violations, and had Tmax values available on Day 1 and Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
Time to reach the maximum plasma concentration (Tmax) of study drug after the dose is given.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
n=4 Participants
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=7 Participants
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
n=4 Participants
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration
Day 12
|
0.75 hour
Interval 0.5 to 1.0
|
1.00 hour
Interval 0.5 to 4.0
|
—
|
1.50 hour
Interval 0.5 to 1.98
|
—
|
1.00 hour
Interval 1.0 to 1.5
|
1.00 hour
Interval 0.5 to 6.0
|
0.98 hour
Interval 0.5 to 2.98
|
|
Time to Maximum Plasma Concentration
Day 1
|
0.75 hour
Interval 0.5 to 23.92
|
0.75 hour
Interval 0.5 to 23.92
|
—
|
3.49 hour
Interval 0.5 to 12.0
|
—
|
1.00 hour
Interval 1.0 to 23.92
|
1.00 hour
Interval 0.98 to 23.92
|
1.49 hour
Interval 0.98 to 6.0
|
SECONDARY outcome
Timeframe: Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.Population: All participants that received MK-5160, had no major protocol violations, and had t1/2 values available on Day 1 and Day 12. t1/2 was not calculated for the Glargine 0.4 U/kg and 0.6 U/kg arms. No participants were randomized to the T1DM MK-5160 64 nmol/kg or T2DM MK-5160 16 nmol/kg arms.
Apparent Terminal Half-life (t1/2) is the time required for a given MK-5160 concentration in the plasma to decrease by 50%.
Outcome measures
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 Participants
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life
|
20.01 hour
Geometric Coefficient of Variation 59.84
|
21.69 hour
Geometric Coefficient of Variation 27.70
|
—
|
—
|
—
|
13.10 hour
Geometric Coefficient of Variation 36.05
|
14.47 hour
Geometric Coefficient of Variation 16.78
|
—
|
Adverse Events
T1DM MK-5160 16 Nmol/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
T1DM MK-5160 32 Nmol/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
T1DM MK-5160 64 Nmol/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
T1DM Glargine 0.4 U/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
T2DM MK-5160 16 Nmol/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
T2DM MK-5160 32 Nmol/kg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
T2DM MK-5160 64 Nmol/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
T2DM Glargine 0.6 U/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
T1DM MK-5160 16 Nmol/kg
n=6 participants at risk
Participants with T1DM received MK-5160, 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 32 Nmol/kg
n=6 participants at risk
Participants with T1DM received MK-5160, 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM MK-5160 64 Nmol/kg
Participants with T1DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T1DM Glargine 0.4 U/kg
n=4 participants at risk
Participants with T1DM received Glargine 0.4 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 16 Nmol/kg
Participants with T2DM received MK-5160 16 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 32 Nmol/kg
n=7 participants at risk
Participants with T2DM received MK-5160 32 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM MK-5160 64 Nmol/kg
n=6 participants at risk
Participants with T2DM received MK-5160 64 nmol/kg, and placebo to glargine daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
T2DM Glargine 0.6 U/kg
n=4 participants at risk
Participants with T2DM received Glargine 0.6 U/kg and placebo to MK-5160 daily for 12 days. Dextrose was administered as needed to maintain blood sugar.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
33.3%
2/6 • Number of events 3 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
14.3%
1/7 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
33.3%
2/6 • Number of events 7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
85.7%
6/7 • Number of events 6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
50.0%
3/6 • Number of events 4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
50.0%
2/4 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
50.0%
2/4 • Number of events 8 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
14.3%
1/7 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
75.0%
3/4 • Number of events 6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
General disorders
Injection site nodule
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
General disorders
Thirst
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
General disorders
Feeling cold
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
14.3%
1/7 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Infections and infestations
Hordeolum
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
2/6 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
50.0%
2/4 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
100.0%
6/6 • Number of events 68 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
83.3%
5/6 • Number of events 54 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
100.0%
4/4 • Number of events 38 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
14.3%
1/7 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
50.0%
3/6 • Number of events 7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
50.0%
2/4 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Metabolism and nutrition disorders
Pseuodohypoglycaemia
|
33.3%
2/6 • Number of events 6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
83.3%
5/6 • Number of events 13 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
75.0%
3/4 • Number of events 6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
28.6%
2/7 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
28.6%
2/7 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
14.3%
1/7 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
33.3%
2/6 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
66.7%
4/6 • Number of events 4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
28.6%
2/7 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
14.3%
1/7 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
28.6%
2/7 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/7 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
14.3%
1/7 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
14.3%
1/7 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
14.3%
1/7 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
50.0%
3/6 • Number of events 4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/6 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
25.0%
1/4 • Number of events 2 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
—
0/0 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
14.3%
1/7 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
16.7%
1/6 • Number of events 1 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
0.00%
0/4 • Up to 33 days
All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.
|
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 trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER