Trial Outcomes & Findings for Single Ascending Dose Study of MK-1092 in Healthy Participants and in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-1092-001) (NCT NCT03170544)
NCT ID: NCT03170544
Last Updated: 2019-11-15
Results Overview
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
COMPLETED
PHASE1
69 participants
Up to 112 days
2019-11-15
Participant Flow
This was a 4-part study, participants received MK-1092 or glargine: Part 1 - healthy adult participants; Part 2, healthy adult participants received MK-1092 and also insulin lispro (Humalog®); Part 3 - adult participants with Type 1 diabetes mellitus; Part 4 had 3 periods (Periods 1, 2, and 3), participants with Type 2 diabetes mellitus.
Participant milestones
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092 8 nmol/kg SC+ Insulin Lipro (Humalog®) 1.2 nmol/kg IV, as a single dose under the euglycemic clamp in healthy participants
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092 SC 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092 SC 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 4 (T2DM) Glargine
Glargine, SC, 3.0 nmol/kg, as a single dose in Periods 1, 2, and 3 under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092
MK-1092, SC, 32-, 16-, and 64 nmol/kg in Periods 1, 2, and 3, respectively, as a single dose under the euglycemic clamp in participants with T2DM
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
10
|
6
|
6
|
7
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
COMPLETED
|
9
|
6
|
6
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
6
|
6
|
0
|
0
|
|
Part 3
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
6
|
6
|
0
|
0
|
|
Part 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 4
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
6
|
|
Part 4
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
6
|
|
Part 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092 8 nmol/kg SC+ Insulin Lipro (Humalog®) 1.2 nmol/kg IV, as a single dose under the euglycemic clamp in healthy participants
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092 SC 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092 SC 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 4 (T2DM) Glargine
Glargine, SC, 3.0 nmol/kg, as a single dose in Periods 1, 2, and 3 under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092
MK-1092, SC, 32-, 16-, and 64 nmol/kg in Periods 1, 2, and 3, respectively, as a single dose under the euglycemic clamp in participants with T2DM
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
Not treated
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Single Ascending Dose Study of MK-1092 in Healthy Participants and in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-1092-001)
Baseline characteristics by cohort
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=10 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=6 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=6 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Humalog
n=4 Participants
MK-1092 8 nmol/kg SC+ Insulin Lipro (Humalog®) 1.2 nmol/kg IV, as a single dose under the euglycemic clamp in healthy participants
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
n=4 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092 8 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
n=6 Participants
MK-1092 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 4 (T2DM) Glargine
n=3 Participants
Glargine, SC, 3.0 nmol/kg, as a single dose in Periods 1, 2, and 3 under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092
n=6 Participants
MK-1092, SC, 32-, 16-, and 64 nmol/kg in Periods 1, 2, and 3, respectively, as a single dose under the euglycemic clamp in participants with T2DM
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.3 Years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
37.5 Years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
33.5 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
34.2 Years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
35.2 Years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
35.0 Years
STANDARD_DEVIATION 5.7 • n=10 Participants
|
45.3 Years
STANDARD_DEVIATION 2.6 • n=115 Participants
|
39.0 Years
STANDARD_DEVIATION 12.0 • n=24 Participants
|
34.2 Years
STANDARD_DEVIATION 10.0 • n=42 Participants
|
40.0 Years
STANDARD_DEVIATION 10.4 • n=42 Participants
|
52.0 Years
STANDARD_DEVIATION 9.6 • n=42 Participants
|
51.5 Years
STANDARD_DEVIATION 4.3 • n=42 Participants
|
38.3 Years
STANDARD_DEVIATION 10.1 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
60 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
19 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
50 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
15 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
51 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Up to 112 daysPopulation: The analysis population included all participants who received at least one dose of the investigational drug. Post-trial adverse events were pooled across treatment groups in each part of the study.
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=10 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=6 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=6 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
n=40 Participants
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
n=4 Participants
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
n=4 Participants
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
n=4 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
n=16 Participants
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
n=3 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
n=3 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
n=3 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
n=6 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
n=6 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
n=9 Participants
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 58 daysPopulation: The analysis population included all participants who received at least one dose of the investigational drug. Post-trial adverse events were pooled across treatment groups in each part of the study.
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=10 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=6 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=6 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
n=40 Participants
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
n=4 Participants
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
n=4 Participants
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
n=4 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
n=16 Participants
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
n=3 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
n=3 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
n=3 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
n=6 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
n=6 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
n=9 Participants
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued the Study Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 24 hours post-dosePopulation: The analysis population included participants in Part 3 who complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations. The glargine-treated group was pooled; n=2 participants per panel.
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (\~every 5 minutes), allowing rapid changes to the rate of glucose infusion. Mean and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 3, 4 participants (across 2 dosing panels) received glargine. These 4 participants were analyzed together given the small numbers and the same treatment (same dose of glargine) received.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=6 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=4 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With Type 1 Diabetes Mellitus (T1DM) (Part 3)
|
1.33 mg/kg/min
Interval 0.63 to 2.04
|
2.74 mg/kg/min
Interval 2.03 to 3.44
|
2.32 mg/kg/min
Interval 1.45 to 3.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 24 hours post-dosePopulation: The analysis population included participants in Part 1 who complied with the protocol sufficiently to ensure that these data likely exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations. The glargine-treated group was pooled; n=2 participants per panel.
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (\~every 5 minutes), allowing rapid changes to the rate of glucose infusion. Mean and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 doses, Glargine). In Part 1, 10 participants (across 5 dosing panels) received glargine. These 10 participants in Part 1 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=6 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=6 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=10 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Healthy Adult Participants (Part 1)
|
0.92 mg/kg/min
Interval 0.2 to 1.64
|
1.69 mg/kg/min
Interval 0.97 to 2.41
|
3.10 mg/kg/min
Interval 2.38 to 3.82
|
3.32 mg/kg/min
Interval 2.6 to 4.04
|
4.39 mg/kg/min
Interval 3.67 to 5.11
|
2.72 mg/kg/min
Interval 2.16 to 3.28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 24 hours post-dosePopulation: The analysis population included participants in Part 4 who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
The GIRmax, following administration of MK-1092 SC or glargine SC, was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (\~every 5 minutes), allowing rapid changes to the rate of glucose infusion. For Part 4, a linear mixed effects model containing a fixed effect for treatment (MK-1092, Glargine), a nested effect from participants within treatment, an interaction between treatment and period (treatment by period: Period = Period 1, 2, 3) and a random effect due to participants was used. MK-1092 was administered to a single cohort of participants in Periods 1, 2, and 3. Glargine was administered to a single cohort of participants as 3.0 nmol/kg SC in Periods 1, 2, and 3.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=6 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=3 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=3 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=3 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With Type 2 Diabetes Mellitus (T2DM) (Part 4)
|
1.90 mg/kg/min
Interval 1.46 to 2.35
|
1.40 mg/kg/min
Interval 0.95 to 1.84
|
2.83 mg/kg/min
Interval 2.38 to 3.27
|
0.93 mg/kg/min
Interval 0.3 to 1.56
|
1.43 mg/kg/min
Interval 0.79 to 2.06
|
1.20 mg/kg/min
Interval 0.57 to 1.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 24 hours post-dosePopulation: The analysis population included participants in Part 1 who complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations. The glargine-treated group was pooled; n=2 participants per panel.
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (\~every 5 minutes), allowing rapid changes to the rate of glucose infusion in Part 1 only. TWA(GIR)= Time-weighted average based on GIR values calculated as AUC (area under the curve) based on GIR values observed from time zero to t divided by t, t= 24 hours. Mean and 95% CI are based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 1, 10 participants (across 5 dosing panels) received glargine. These 10 participants in Part 1 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=6 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=6 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=10 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Healthy Adult Participants (Part 1)
|
0.49 mg/kg/min
Interval 0.0 to 0.99
|
0.97 mg/kg/min
Interval 0.47 to 1.47
|
2.02 mg/kg/min
Interval 1.52 to 2.52
|
1.97 mg/kg/min
Interval 1.47 to 2.47
|
2.87 mg/kg/min
Interval 2.37 to 3.37
|
1.70 mg/kg/min
Interval 1.32 to 2.09
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 24 hours post-dosePopulation: The analysis population included participants in Part 3 who complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment. Compliance included exposure to treatment, availability of measurements, absence of major protocol deviations. The glargine treatment group was pooled (n=2 participants per panel).
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (\~every 5 minutes), allowing rapid changes to the rate of glucose infusion in Part 3 only. TWA(GIR)= Time-weighted average based on GIR values calculated as AUC (area under the curve) based on GIR values observed from time zero to t divided by t, t= 24 hours. Mean and 95% CI are based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 3, 4 participants (across 2 dosing panels) received glargine. These 4 participants were analyzed together given the small numbers and same treatment (same dose of glargine) received.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=6 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=4 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With T1DM (Part 3)
|
0.72 mg/kg/min
Interval 0.18 to 1.27
|
1.92 mg/kg/min
Interval 1.38 to 2.46
|
1.18 mg/kg/min
Interval 0.52 to 1.85
|
—
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SECONDARY outcome
Timeframe: Up to approximately 24 hours post-dosePopulation: The analysis population included participants in Part 4 who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (\~every 5 minutes), allowing rapid changes to the rate of glucose infusion in Part 4 only. TWA(GIR)= Time-weighted average based on GIR values calculated as AUC (area under the curve) based on GIR values observed from time zero to t divided by t, t= 24 hours. Mean and 95% CI were based on a linear mixed effects model containing a fixed effect for treatment (MK, Glargine), period (Period 1, Period 2 and Period 3), a nested effect from participants within treatment, and interaction between treatment and period. MK-1092 or glargine was administered to a single cohort of participants in Periods 1, 2, and 3.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=6 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=3 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=3 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=3 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With T2DM (Part 4)
|
1.02 mg/kg/min
Interval 0.83 to 1.21
|
0.78 mg/kg/min
Interval 0.59 to 0.97
|
1.70 mg/kg/min
Interval 1.51 to 1.89
|
0.50 mg/kg/min
Interval 0.23 to 0.77
|
0.64 mg/kg/min
Interval 0.37 to 0.91
|
0.67 mg/kg/min
Interval 0.4 to 0.94
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Parts 1 and 3 who received MK-1092 and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=6 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=6 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=6 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
n=6 Participants
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximal Plasma MK-1092 Concentration (Cmax) Parts 1 and 3
|
0.382 nM
Geometric Coefficient of Variation 21.7
|
0.747 nM
Geometric Coefficient of Variation 25.0
|
1.63 nM
Geometric Coefficient of Variation 12.7
|
2.91 nM
Geometric Coefficient of Variation 18.7
|
6.82 nM
Geometric Coefficient of Variation 27.6
|
0.788 nM
Geometric Coefficient of Variation 20.4
|
3.43 nM
Geometric Coefficient of Variation 18.4
|
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Parts 1 \& 3 who received MK-1092 and complied with the protocol (exposure to treatment, availability of measurements, absence of major protocol deviations) so that data exhibited effects of treatment. For the MK-1092 4.0 nmol/kg group, 5 participants were excluded (insufficient terminal phase data).
AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=1 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=6 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=6 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
n=6 Participants
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) MK-1092 Parts 1 and 3
|
10.6 nM*hr
Geometric Coefficient of Variation NA
Datum from only one participant was available so there is no associated percent geometric coefficient of variation.
|
17.2 nM*hr
Geometric Coefficient of Variation 12.0
|
37.5 nM*hr
Geometric Coefficient of Variation 11.5
|
76.0 nM*hr
Geometric Coefficient of Variation 10.2
|
161 nM*hr
Geometric Coefficient of Variation 14.1
|
21.5 nM*hr
Geometric Coefficient of Variation 22.2
|
74.9 nM*hr
Geometric Coefficient of Variation 30.5
|
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—
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Parts 1 \& 3 who received MK-1092 and complied with the protocol (exposure to treatment, availability of measurements, absence of major protocol deviations) so that data exhibited effects of treatment. For the MK-1092 4.0 nmol/kg group, 5 participants were excluded (insufficient terminal phase data).
CL/F is the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways after the dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=1 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=6 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=6 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
n=6 Participants
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Rate of Plasma Drug Removal (CL/F) MK-1092 Parts 1 and 3
|
25.6 L/hr
Geometric Coefficient of Variation NA
Datum from only one participant was available so there is no associated percent geometric coefficient of variation.
|
35.0 L/hr
Geometric Coefficient of Variation 13.3
|
33.8 L/hr
Geometric Coefficient of Variation 19.8
|
32.2 L/hr
Geometric Coefficient of Variation 16.1
|
31.7 L/hr
Geometric Coefficient of Variation 13.9
|
33.6 L/hr
Geometric Coefficient of Variation 28.1
|
35.9 L/hr
Geometric Coefficient of Variation 26.6
|
—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Parts 1 and 3 who received MK-1092 and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Parts 1 and 3 only.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=6 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=6 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=6 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=6 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
n=6 Participants
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma MK-1092 Concentration (Tmax) Parts 1 and 3
|
18.00 Hours
Interval 9.0 to 18.0
|
12.00 Hours
Interval 4.0 to 18.0
|
18.00 Hours
Interval 4.0 to 24.0
|
18.00 Hours
Interval 9.0 to 18.0
|
12.00 Hours
Interval 12.0 to 18.0
|
15.00 Hours
Interval 9.0 to 18.0
|
15.04 Hours
Interval 9.0 to 18.0
|
—
|
—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Parts 1 and 3 who received MK-1092 and complied with the protocol (treatments, measurements, major protocol deviations) so that data exhibited effects of treatment. For the MK-1092 4.0 and 64 nmol/kg groups, 5 and 1 participants, respectively, were excluded (insufficient terminal phase data).
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=1 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=6 Participants
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=5 Participants
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=6 Participants
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
n=6 Participants
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach a 50% Decrease In Plasma MK-1092 Concentration (t1/2) Parts 1 and 3
|
6.39 Hours
Geometric Coefficient of Variation NA
Datum from only one participant was available so there is no associated percent geometric coefficient of variation. .
|
6.17 Hours
Geometric Coefficient of Variation 29.3
|
5.41 Hours
Geometric Coefficient of Variation 28.7
|
5.84 Hours
Geometric Coefficient of Variation 16.5
|
9.27 Hours
Geometric Coefficient of Variation 71.1
|
8.54 Hours
Geometric Coefficient of Variation 23.2
|
6.70 Hours
Geometric Coefficient of Variation 31.4
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
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—
|
SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Part 4 who received MK-1092 and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=6 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximal Plasma MK-1092 Concentration (Cmax) Part 4
|
1.72 nM
Geometric Coefficient of Variation 46.0
|
1.14 nM
Geometric Coefficient of Variation 32.6
|
3.60 nM
Geometric Coefficient of Variation 23.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Part 4 who received MK-1092 and complied with the protocol (exposure to treatment, measurement availability, major protocol deviations) so that data exhibited effects of treatment. Seven participants (Period 1:1; Period 2:3; Period 3:3) were excluded due to insufficient terminal phase data.
AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=5 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=3 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=3 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) MK-1092 Part 4
|
46.1 nM*hr
Geometric Coefficient of Variation 34.4
|
32.7 nM*hr
Geometric Coefficient of Variation 48.8
|
111 nM*hr
Geometric Coefficient of Variation 20.7
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Parts 4 who received MK-1092 and complied with the protocol (exposure to treatment, measurement availability, major protocol deviations) so that data exhibited effects of treatment. Seven participants (Period 1:1; Period 2:3; Period 3:3) were excluded due to insufficient terminal phase data.
CL/F is the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways after the dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=5 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=3 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=3 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Rate of Plasma Drug Removal (CL/F) MK-1092 Part 4
|
55.6 L/hr
Geometric Coefficient of Variation 27.4
|
45.9 L/hr
Geometric Coefficient of Variation 52.5
|
40.7 L/hr
Geometric Coefficient of Variation 13.5
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Part 4 who received MK-1092 and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Part 4 only.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=6 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma MK-1092 Concentration (Tmax) Part 4
|
14.99 Hours
Interval 9.0 to 18.0
|
18.00 Hours
Interval 12.0 to 18.0
|
21.04 Hours
Interval 18.0 to 24.0
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Part 4 who received MK-1092 and complied with the protocol (exposure to treatment, measurement availability, major protocol deviations) so that data exhibited effects of treatment. Seven participants (Period 1:1; Period 2:3; Period 3:3) were excluded due to insufficient terminal phase data.
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=5 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=3 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=3 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach a 50% Decrease In Plasma MK-1092 Concentration (t1/2) Part 4
|
8.26 Hours
Geometric Coefficient of Variation 39.1
|
9.09 Hours
Geometric Coefficient of Variation 20.4
|
7.28 Hours
Geometric Coefficient of Variation 30.6
|
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Parts 1 and 3 who received glargine and complied with the protocol sufficiently so that the data exhibited effects of treatment. One participant (Part 1) was excluded (no quantifiable glargine concentration). Data across panels were pooled for Parts 1 and 3.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation. In Part 1, 9 participants (across 5 dosing panels) received glargine and had quantifiable glargine levels, and, in Part 3, 4 participants (across 2 dosing panels) received glargine and had quantifiable glargine levels. These 9 participants in Part 1 were analyzed together and these 4 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=9 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=4 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximal Plasma Insulin Glargine Concentration (Cmax) Parts 1 and 3
|
115 pg/mL
Geometric Coefficient of Variation 48.4
|
186 pg/mL
Geometric Coefficient of Variation 33.8
|
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Parts 1 and 3 who received glargine and complied with the protocol sufficiently so that the data exhibited the effects of treatment. Two participants in Part 1 and 1 in Part 3 were excluded due to insufficient terminal phase data. Data across panels were pooled for Parts 1 and 3.
AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation. In Part 1, 8 participants (across 5 dosing panels) received glargine and had sufficient terminal phase data, and, in Part 3, 3 participants (across 2 dosing panels) received glargine and had sufficient terminal phase data. These 8 participants in Part 1 were analyzed together and these 3 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=8 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=3 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) Insulin Glargine Parts 1 and 3
|
3180 hr*pg/mL
Geometric Coefficient of Variation 44.7
|
4240 hr*pg/mL
Geometric Coefficient of Variation 93.9
|
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Parts 1 and 3 who received glargine and complied with the protocol so that data likely exhibited effects of treatment. One participant (Part 1) was excluded (no quantifiable glargine concentration). Data across panels were pooled for Parts 1 and 3.
Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. In Part 1, 9 participants (across 5 dosing panels) received glargine and had quantifiable glargine levels, and, in Part 3, 4 participants (across 2 dosing panels) received glargine and had quantifiable glargine levels. These 9 participants in Part 1 were analyzed together and these 4 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=9 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=4 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Insulin Glargine Concentration (Tmax) Parts 1 and 3
|
1.98 Hours
Interval 0.48 to 11.97
|
1.74 Hours
Interval 0.5 to 3.0
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Parts 1 and 3 who received glargine and sufficiently complied with the protocol so that the data exhibited the effects of treatment. Two participants excluded in Part 1 and 1 participant excluded in Part 3 due to insufficient terminal phase data. Data across panels were pooled for Parts 1 and 3.
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation. In Part 1, 8 participants (across 5 dosing panels) received glargine and had sufficient terminal phase data, and, in Part 3, 3 participants (across 2 dosing panels) received glargine and sufficient terminal phase data. These 8 participants in Part 1 were analyzed together and these 3 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=8 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=3 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach a 50% Decrease In Plasma Insulin Glargine Concentration (t1/2) Parts 1 and 3
|
18.8 Hours
Geometric Coefficient of Variation 64.5
|
15.0 Hours
Geometric Coefficient of Variation 65.8
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Part 4 who received glargine and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=3 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=3 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=3 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximal Plasma Insulin Glargine Concentration (Cmax) Part 4
|
85.6 pg/mL
Geometric Coefficient of Variation 18.0
|
91.9 pg/mL
Geometric Coefficient of Variation 35.1
|
105 pg/mL
Geometric Coefficient of Variation 33.9
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)Population: The analysis population included participants in Part 4 who received glargine and complied with the protocol (exposure to treatment, availability of measurements, major protocol deviations) so that data exhibited effects of treatment. Five participants (Period 1:1; Period 2:2; Period 3:2) were excluded due to insufficient terminal phase data.
AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=2 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=1 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=1 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) Insulin Glargine Part 4
|
4960 hr*pg/mL
Geometric Coefficient of Variation 66.2
|
928 hr*pg/mL
Geometric Coefficient of Variation NA
Datum from only one participant was available so there is no associated geometric coefficient of variation.
|
8020 hr*pg/mL
Geometric Coefficient of Variation NA
Datum from only one participant was available so there is no associated geometric coefficient of variation.
|
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28) ]Population: The analysis population included participants in Part 4 who received glargine and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.
Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Part 4 only.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=3 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=3 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=3 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Insulin Glargine Concentration (Tmax) Part 4
|
1.00 Hr
Interval 0.98 to 11.98
|
2.00 Hr
Interval 1.0 to 9.0
|
2.98 Hr
Interval 1.0 to 11.98
|
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SECONDARY outcome
Timeframe: -15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28) ]Population: The analysis population included participants in Part 4 who received glargine and complied with the protocol (exposure to treatment, availability of measurements, major protocol deviations) so that data exhibited effects of treatment. Five participants (Period 1:1; Period 2:2; Period 3:2) were excluded due to insufficient terminal phase data.
t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.
Outcome measures
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=2 Participants
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=1 Participants
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=1 Participants
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-Trial
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
MK-1092, (8.0 nmol/kg based on Part 1), SC, as a single dose under the euglycemic clamp in participants with T1DM.
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
MK-1092, 32 nmol/kg, SC, as a single dose, in participants with T1DM
|
Part 3 (T1DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4, (T2DM) MK-1092 64 Nmol/kg (Period 3)
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach a 50% Decrease In Plasma Insulin Glargine Concentration (t1/2) Part 4
|
45.2 Hours
Geometric Coefficient of Variation 53.2
|
8.10 Hours
Geometric Coefficient of Variation NA
Datum from only one participant was available so there is no associated geometric coefficient of variation.
|
46.5 Hours
Geometric Coefficient of Variation NA
Data from only one participant was available so there is no associated geometric coefficient of variation.
|
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Adverse Events
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
Part 1 (Healthy Adults) Post-trial
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-trial
Part 3 (T1DM) Glargine 3.0 Nmol/kg
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
Part 3 (T1DM) MK-1092 32 Nmol/kg
Part 3 (T1DM) Post-trial
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
Part 4 (T2DM) 64 Nmol/kg (Period 3)
Part 4 (T2DM) Post-Trial
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 (Healthy Adults) Glargine 3.0 Nmol/kg
n=10 participants at risk
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 4.0 Nmol/kg
n=6 participants at risk
MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 8.0 Nmol/kg
n=6 participants at risk
MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 16 Nmol/kg
n=6 participants at risk
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 32 Nmol/kg
n=6 participants at risk
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) MK-1092 64 Nmol/kg
n=6 participants at risk
MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp in healthy participants
|
Part 1 (Healthy Adults) Post-trial
n=40 participants at risk
Glargine or MK-1091 as a single dose under the euglycemic clamp in healthy adults in the Post-trial period
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro
n=4 participants at risk
MK-1092, 8.0 nmol/kg dose selection based on Part 1 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants
|
Part 2 (Healthy Adults) MK-1092 + Insulin Lipro Post-trial
n=4 participants at risk
MK-1092, 8.0 nmol/kg selection based on Part 2 + Insulin lipro (Humalog®), 1.2 nmol/kg, as a single dose under the euglycemic clamp in healthy participants in the Post-trial period
|
Part 3 (T1DM) Glargine 3.0 Nmol/kg
n=4 participants at risk
Glargine 3.0 nmol/kg SC as a single dose under euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 8.0 Nmol/kg
n=6 participants at risk
MK-1092 8.0 nmol/kg SC as a single dose under euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) MK-1092 32 Nmol/kg
n=6 participants at risk
MK-1092 32 nmol/kg SC as a single dose under euglycemic clamp in participants with T1DM
|
Part 3 (T1DM) Post-trial
n=16 participants at risk
Glargine or MK-1092 as a single dose under the euglycemic clamp in participants with T1DM in the Post-trial period
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 1)
n=3 participants at risk
Glargine 3.0 nmol/kg, SC, as a single dose under euglycemic clamp in participants with T1DM in Period 1
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 2)
n=3 participants at risk
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 2
|
Part 4 (T2DM) Glargine 3.0 Nmol/kg (Period 3)
n=3 participants at risk
Glargine, 3.0 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM in Period 3
|
Part 4 (T2DM) MK-1092 32 Nmol/kg (Period 1)
n=6 participants at risk
MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) MK-1092 16 Nmol/kg (Period 2)
n=6 participants at risk
MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) 64 Nmol/kg (Period 3)
n=6 participants at risk
MK-1092, 64 nmol/kg dose as a single dose under euglycemic clamp in participants with T2DM
|
Part 4 (T2DM) Post-Trial
n=9 participants at risk
Glargine or MK-1092 as a single dose under euglycemic clamp in participants with T2DM in the Post-trial period
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
25.0%
1/4 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
General disorders
Administration site extravasation
|
10.0%
1/10 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
General disorders
Application site dermatitis
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
General disorders
Injection site pain
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
50.0%
3/6 • Number of events 3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
50.0%
3/6 • Number of events 3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 2 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
25.0%
1/4 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
33.3%
1/3 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
33.3%
1/3 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
33.3%
2/6 • Number of events 2 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
25.0%
1/4 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
25.0%
1/4 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 2 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
33.3%
1/3 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
33.3%
2/6 • Number of events 2 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
33.3%
1/3 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
25.0%
1/4 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
25.0%
1/4 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
33.3%
2/6 • Number of events 2 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
50.0%
2/4 • Number of events 6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
100.0%
6/6 • Number of events 11 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
50.0%
3/6 • Number of events 5 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
12.5%
2/16 • Number of events 2 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Metabolism and nutrition disorders
Pseudohypoglycaemia
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
25.0%
1/4 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
33.3%
2/6 • Number of events 3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
25.0%
1/4 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/40 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/4 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
16.7%
1/6 • Number of events 1 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/16 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/3 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/6 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
0.00%
0/9 • Up to 112 days
Post-trial adverse events were pooled across the arms in each part of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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