Trial Outcomes & Findings for A Study of LY900014 in Healthy Chinese Participants (NCT NCT04049123)
NCT ID: NCT04049123
Last Updated: 2021-11-16
Results Overview
PK: Insulin Lispro AUC(0-10h)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose
Results posted on
2021-11-16
Participant Flow
This was a 3-period crossover study in which participants received a single 7 Unit (U), and a single 15 U subcutaneous (SC) dose of LY900014 in two of three dosing sequences, and 15 U SC dose of Humalog in one of three dosing sequences. There was a washout period of ≥ 3 days between euglycemic clamp visits.
Participant milestones
| Measure |
Sequence 1: CAB
Participants received a single SC dose in each treatment period.
C = 15 U Humalog
A = 7 U LY900014
B = 15 U LY900014
|
Sequence 2: ACB
Participants received a single SC dose in each treatment period.
A = 7 U LY900014
C = 15 U Humalog
B = 15 U LY900014
|
Sequence 3: ABC
Participants received a single SC dose in each treatment period.
A = 7 U LY900014
B = 15 U LY900014
C = 15 U Humalog
|
|---|---|---|---|
|
Period 1
STARTED
|
5
|
5
|
5
|
|
Period 1
Received at Least One Dose of Study Drug
|
5
|
5
|
5
|
|
Period 1
COMPLETED
|
5
|
5
|
5
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2
STARTED
|
5
|
5
|
5
|
|
Period 2
COMPLETED
|
5
|
5
|
5
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 3
STARTED
|
5
|
5
|
5
|
|
Period 3
COMPLETED
|
5
|
5
|
5
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY900014 in Healthy Chinese Participants
Baseline characteristics by cohort
| Measure |
Overall Baseline
n=15 Participants
Participants received a single 7 U, and a single 15 U SC dose of LY900014 in 2 of 3 periods and 15 U SC dose of Humalog in 1 of 3 periods.
|
|---|---|
|
Age, Continuous
|
27.0 years
STANDARD_DEVIATION 3.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 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
|
15 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
China
|
15 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdosePopulation: All participants who received at least one dose of study drug and have evaluable PK data.
PK: Insulin Lispro AUC(0-10h)
Outcome measures
| Measure |
7 U LY900014
n=15 Participants
Single SC dose 7 U LY900014.
|
15 U LY900014
n=15 Participants
Single SC dose 15 U LY900014.
|
15 U Humalog
n=15 Participants
Single SC dose 15 U Humalog.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h])
|
708 picomole * hour per Liter (pmol*h/L)
Geometric Coefficient of Variation 12
|
1580 picomole * hour per Liter (pmol*h/L)
Geometric Coefficient of Variation 11
|
1600 picomole * hour per Liter (pmol*h/L)
Geometric Coefficient of Variation 12
|
SECONDARY outcome
Timeframe: Day 1: Predose: -10, -20, -30 minutes; During clamp: every 2.5 to 3 minutes for the first 30 minutes; every 5 minutes for 30 to 120 minutes; every 10 minutes for 120 to 480 minutes and every 20 minutes for 480 to 600 minutes postdosePopulation: All participants who received at least one dose of study drug and had evaluable glucodynamic (GD) data.
Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period.
Outcome measures
| Measure |
7 U LY900014
n=15 Participants
Single SC dose 7 U LY900014.
|
15 U LY900014
n=15 Participants
Single SC dose 15 U LY900014.
|
15 U Humalog
n=15 Participants
Single SC dose 15 U Humalog.
|
|---|---|---|---|
|
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
|
989 milligram per kilogram (mg/kg)
Geometric Coefficient of Variation 35
|
1540 milligram per kilogram (mg/kg)
Geometric Coefficient of Variation 40
|
1720 milligram per kilogram (mg/kg)
Geometric Coefficient of Variation 32
|
Adverse Events
7 Unit (U) LY900014
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
15 U LY900014
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
15 U Humalog
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
7 Unit (U) LY900014
n=15 participants at risk
Single subcutaneous (SC) dose 7 U LY900014.
|
15 U LY900014
n=15 participants at risk
Single SC dose 15 U LY900014.
|
15 U Humalog
n=15 participants at risk
Single SC dose 15 U Humalog.
|
|---|---|---|---|
|
Cardiac disorders
Nodal rhythm
|
6.7%
1/15 • Number of events 1 • Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
|
0.00%
0/15 • Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
|
0.00%
0/15 • Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/15 • Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
|
6.7%
1/15 • Number of events 1 • Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
|
0.00%
0/15 • Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
|
6.7%
1/15 • Number of events 1 • Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
|
0.00%
0/15 • Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/15 • Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
|
20.0%
3/15 • Number of events 3 • Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
|
0.00%
0/15 • Baseline to end of study (up to 183 days).
All enrolled participants, whether or not they completed all protocol requirements.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60