Trial Outcomes & Findings for A Study of LY900014 in Japanese Participants With Type 1 Diabetes Mellitus (NCT NCT03407118)
NCT ID: NCT03407118
Last Updated: 2020-05-01
Results Overview
PK: Insulin Lispro AUC from time zero to 10 hours
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Predose, 5 minutes (min), 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min, 45 min, 50 min, 55 min, 60 min, 70 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min, 540 min, and 600 min postdose
Results posted on
2020-05-01
Participant Flow
Participant milestones
| Measure |
LY900014\Insulin Lispro (Humalog)
Period 1: A single dose of 15 Units (U) LY900014 administered subcutaneously (SC) .
Period 2: A single dose of 15 U insulin lispro (Humalog) administered SC with up to 28 days between doses
|
Insulin Lispro (Humalog)\LY900014
Period 1: A single dose of 15 U insulin lispro (Humalog) administered SC.
Period 2: A single dose of 15 Units (U) LY900014 administered subcutaneously (SC) . with up to 28 days between doses.
|
|---|---|---|
|
Period 1
STARTED
|
14
|
17
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
14
|
17
|
|
Period 1
COMPLETED
|
14
|
17
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
14
|
17
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
13
|
17
|
|
Period 2
COMPLETED
|
13
|
17
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
LY900014\Insulin Lispro (Humalog)
Period 1: A single dose of 15 Units (U) LY900014 administered subcutaneously (SC) .
Period 2: A single dose of 15 U insulin lispro (Humalog) administered SC with up to 28 days between doses
|
Insulin Lispro (Humalog)\LY900014
Period 1: A single dose of 15 U insulin lispro (Humalog) administered SC.
Period 2: A single dose of 15 Units (U) LY900014 administered subcutaneously (SC) . with up to 28 days between doses.
|
|---|---|---|
|
Period 2
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study of LY900014 in Japanese Participants With Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
All Participants
n=31 Participants
All randomized participants who received at least 1 dose of study drug.
|
|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Japan
|
31 Participants
n=99 Participants
|
|
Weight
|
59.62 kilograms
STANDARD_DEVIATION 8.29 • n=99 Participants
|
|
Height
|
161.35 centimeters
STANDARD_DEVIATION 7.44 • n=99 Participants
|
|
Body Mass Index
|
22.85 kilograms per meter squared
STANDARD_DEVIATION 2.44 • n=99 Participants
|
PRIMARY outcome
Timeframe: Predose, 5 minutes (min), 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min, 45 min, 50 min, 55 min, 60 min, 70 min, 90 min, 120 min, 150 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min, 540 min, and 600 min postdosePopulation: All randomized participants who received at least 1 dose of study drug and had evaluable PK parameters.
PK: Insulin Lispro AUC from time zero to 10 hours
Outcome measures
| Measure |
15 U LY900014
n=31 Participants
A single dose of 15 Units (U) LY900014 administered subcutaneously (SC) in one of two study periods.
|
15 U Insulin Lispro (Humalog)
n=30 Participants
A single dose of 15 U insulin lispro (Humalog) administered SC in one of two study periods.
|
|---|---|---|
|
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to 10 Hours (AUC 0-10h) Following Administration of Each Treatment Arm
|
1930 picomols times hour per Liter
Geometric Coefficient of Variation 59
|
1980 picomols times hour per Liter
Geometric Coefficient of Variation 20
|
SECONDARY outcome
Timeframe: Predose, every minute from run-in and for the duration of the EC until up to 10 hours postdosePopulation: All randomized participants who received at least 1 dose of study drug and had evaluable GD data.
Gtot Over Duration of Clamp for Each Treatment Arm. Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp (EC) procedure. During the euglycemic clamp procedure, blood glucose concentrations are held constant after the administration of study treatment by adjusting the exogenous glucose infusion rate.
Outcome measures
| Measure |
15 U LY900014
n=31 Participants
A single dose of 15 Units (U) LY900014 administered subcutaneously (SC) in one of two study periods.
|
15 U Insulin Lispro (Humalog)
n=30 Participants
A single dose of 15 U insulin lispro (Humalog) administered SC in one of two study periods.
|
|---|---|---|
|
Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Treatment Arm
|
1190 milligrams per kilogram
Geometric Coefficient of Variation 54
|
1250 milligrams per kilogram
Geometric Coefficient of Variation 34
|
Adverse Events
LY900014
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Insulin Lispro (Humalog)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY900014
n=31 participants at risk
A single dose of 15 Units (U) LY900014 administered subcutaneously (SC) . in one of two study periods.
|
Insulin Lispro (Humalog)
n=30 participants at risk
A single dose of 15 U insulin lispro (Humalog) administered SC in one of two study periods.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
9.7%
3/31 • Number of events 3 • Baseline up to 56 weeks
All randomized participants.
|
3.3%
1/30 • Number of events 1 • Baseline up to 56 weeks
All randomized participants.
|
|
Gastrointestinal disorders
vomiting
|
6.5%
2/31 • Number of events 2 • Baseline up to 56 weeks
All randomized participants.
|
6.7%
2/30 • Number of events 2 • Baseline up to 56 weeks
All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • Number of events 1 • Baseline up to 56 weeks
All randomized participants.
|
6.7%
2/30 • Number of events 2 • Baseline up to 56 weeks
All randomized participants.
|
|
Nervous system disorders
Headache
|
9.7%
3/31 • Number of events 4 • Baseline up to 56 weeks
All randomized participants.
|
13.3%
4/30 • Number of events 4 • Baseline up to 56 weeks
All randomized participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60