Trial Outcomes & Findings for A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants (NCT NCT03286751)
NCT ID: NCT03286751
Last Updated: 2020-05-01
Results Overview
Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose \[AUC(0-10h)\]
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose
Results posted on
2020-05-01
Participant Flow
This was a 6-period crossover study in which participants received a single 7 Unit (U), 15 U, or 30 U subcutaneous (SC) dose of LY900014 or Humalog in one of six sequences. There was a washout period of ≥ 3 days between each euglycemic clamp procedure.
Participant milestones
| Measure |
Sequence 1: ABFCED
Participants received a single SC dose in each treatment period.
A = 7 U LY900014
B = 15 U LY900014
F = 30 U Humalog
C = 30 U LY900014
E = 15 U Humalog
D = 7 U Humalog
|
Sequence 2: BCADFE
Participants received a single SC dose in each treatment period.
B = 15 U LY900014
C = 30 U LY900014
A = 7 U LY900014
D = 7 U Humalog
F = 30 U Humalog
E = 15 U Humalog
|
Sequence 3: CDBEAF
Participants received a single SC dose in each treatment period.
C = 30 U LY900014
D = 7 U Humalog
B = 15 U LY900014
E = 15 U Humalog
A = 7 U LY900014
F = 30 U Humalog
|
Sequence 4: DECFBA
Participants received a single SC dose in each treatment period.
D = 7 U Humalog
E = 15 U Humalog
C = 30 U LY900014
F = 30 U Humalog
B = 15 U LY900014
A = 7 U LY900014
|
Sequence 5: EFDACB
Participants received a single SC dose in each treatment period.
E = 15 U Humalog
F = 30 U Humalog
D = 7 U Humalog
A = 7 U LY900014
C = 30 U LY900014
B = 15 U LY900014
|
Sequence 6: FAEBDC
Participants received a single SC dose in each treatment period.
F = 30 U Humalog
A = 7 U LY900014
E = 15 U Humalog
B = 15 U LY900014
D = 7 U Humalog
C = 30 U LY900014
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
7
|
7
|
7
|
7
|
7
|
7
|
|
Period 1
Received at Least One Dose of Study Drug
|
7
|
7
|
7
|
7
|
7
|
7
|
|
Period 1
COMPLETED
|
7
|
7
|
7
|
7
|
7
|
7
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 1
STARTED
|
7
|
7
|
7
|
7
|
7
|
7
|
|
Washout Period 1
COMPLETED
|
7
|
7
|
7
|
7
|
6
|
7
|
|
Washout Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2
STARTED
|
7
|
7
|
7
|
7
|
6
|
7
|
|
Period 2
COMPLETED
|
7
|
7
|
7
|
7
|
6
|
7
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2
STARTED
|
7
|
7
|
7
|
7
|
6
|
7
|
|
Washout Period 2
COMPLETED
|
7
|
6
|
7
|
7
|
6
|
7
|
|
Washout Period 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
7
|
6
|
7
|
7
|
6
|
7
|
|
Period 3
COMPLETED
|
7
|
6
|
7
|
7
|
6
|
7
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 3
STARTED
|
7
|
6
|
7
|
7
|
6
|
7
|
|
Washout Period 3
COMPLETED
|
7
|
6
|
7
|
7
|
6
|
7
|
|
Washout Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
7
|
6
|
7
|
7
|
6
|
7
|
|
Period 4
COMPLETED
|
7
|
6
|
7
|
7
|
6
|
7
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 4
STARTED
|
7
|
6
|
7
|
7
|
6
|
7
|
|
Washout Period 4
COMPLETED
|
7
|
6
|
7
|
7
|
6
|
7
|
|
Washout Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 5
STARTED
|
7
|
6
|
7
|
7
|
6
|
7
|
|
Period 5
COMPLETED
|
7
|
6
|
7
|
7
|
6
|
7
|
|
Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 5
STARTED
|
7
|
6
|
7
|
7
|
6
|
7
|
|
Washout Period 5
COMPLETED
|
7
|
6
|
7
|
7
|
5
|
7
|
|
Washout Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 6
STARTED
|
7
|
6
|
7
|
7
|
5
|
7
|
|
Period 6
COMPLETED
|
7
|
6
|
7
|
7
|
5
|
7
|
|
Period 6
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: ABFCED
Participants received a single SC dose in each treatment period.
A = 7 U LY900014
B = 15 U LY900014
F = 30 U Humalog
C = 30 U LY900014
E = 15 U Humalog
D = 7 U Humalog
|
Sequence 2: BCADFE
Participants received a single SC dose in each treatment period.
B = 15 U LY900014
C = 30 U LY900014
A = 7 U LY900014
D = 7 U Humalog
F = 30 U Humalog
E = 15 U Humalog
|
Sequence 3: CDBEAF
Participants received a single SC dose in each treatment period.
C = 30 U LY900014
D = 7 U Humalog
B = 15 U LY900014
E = 15 U Humalog
A = 7 U LY900014
F = 30 U Humalog
|
Sequence 4: DECFBA
Participants received a single SC dose in each treatment period.
D = 7 U Humalog
E = 15 U Humalog
C = 30 U LY900014
F = 30 U Humalog
B = 15 U LY900014
A = 7 U LY900014
|
Sequence 5: EFDACB
Participants received a single SC dose in each treatment period.
E = 15 U Humalog
F = 30 U Humalog
D = 7 U Humalog
A = 7 U LY900014
C = 30 U LY900014
B = 15 U LY900014
|
Sequence 6: FAEBDC
Participants received a single SC dose in each treatment period.
F = 30 U Humalog
A = 7 U LY900014
E = 15 U Humalog
B = 15 U LY900014
D = 7 U Humalog
C = 30 U LY900014
|
|---|---|---|---|---|---|---|
|
Washout Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Washout Period 2
Personal Reasons
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Washout Period 5
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall
n=42 Participants
All participants who received at least on dose of study drug.
|
|---|---|
|
Age, Continuous
|
41.9 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose \[AUC(0-10h)\]
Outcome measures
| Measure |
7 U Humalog
n=40 Participants
Single SC dose 7 U Humalog.
|
7 U LY900014
n=40 Participants
Single SC dose 7 U LY900014.
|
15 U Humalog
n=41 Participants
Single SC dose 15 U Humalog.
|
15 U LY900014
n=40 Participants
Single SC dose 15 U LY900014.
|
30 U Humalog
n=40 Participants
Single SC dose 30 U Humalog.
|
30 U LY900014
n=41 Participants
Single SC dose 30 U LY900014.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)
|
649 picomole * hour per liter(pmol*/L)
Geometric Coefficient of Variation 16
|
656 picomole * hour per liter(pmol*/L)
Geometric Coefficient of Variation 17
|
1400 picomole * hour per liter(pmol*/L)
Geometric Coefficient of Variation 19
|
1450 picomole * hour per liter(pmol*/L)
Geometric Coefficient of Variation 17
|
3050 picomole * hour per liter(pmol*/L)
Geometric Coefficient of Variation 18
|
3180 picomole * hour per liter(pmol*/L)
Geometric Coefficient of Variation 20
|
SECONDARY outcome
Timeframe: Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dosePopulation: All participants who received at least one dose of study drug and completed at least one clamp procedure.
Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
Outcome measures
| Measure |
7 U Humalog
n=40 Participants
Single SC dose 7 U Humalog.
|
7 U LY900014
n=40 Participants
Single SC dose 7 U LY900014.
|
15 U Humalog
n=41 Participants
Single SC dose 15 U Humalog.
|
15 U LY900014
n=40 Participants
Single SC dose 15 U LY900014.
|
30 U Humalog
n=40 Participants
Single SC dose 30 U Humalog.
|
30 U LY900014
n=41 Participants
Single SC dose 30 U LY900014.
|
|---|---|---|---|---|---|---|
|
Glucodynamics: Total Amount of Glucose Infused (Gtot)
|
1120 milligrams per kilogram (mg/kg)
Geometric Coefficient of Variation 53
|
1080 milligrams per kilogram (mg/kg)
Geometric Coefficient of Variation 60
|
1970 milligrams per kilogram (mg/kg)
Geometric Coefficient of Variation 44
|
1860 milligrams per kilogram (mg/kg)
Geometric Coefficient of Variation 45
|
3290 milligrams per kilogram (mg/kg)
Geometric Coefficient of Variation 32
|
3030 milligrams per kilogram (mg/kg)
Geometric Coefficient of Variation 36
|
Adverse Events
7 U LY900014
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
15 U LY900014
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
30 U LY900014
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
7 U Humalog
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
15 U Humalog
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
30 U Humalog
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
7 U LY900014
n=40 participants at risk
Single SC dose 7 U LY900014.
|
15 U LY900014
n=40 participants at risk
Single SC dose 15 U LY900014.
|
30 U LY900014
n=41 participants at risk
Single SC dose 30 U LY900014.
|
7 U Humalog
n=40 participants at risk
Single SC dose 7 U Humalog.
|
15 U Humalog
n=41 participants at risk
Single SC dose 15 U Humalog.
|
30 U Humalog
n=40 participants at risk
Single SC dose 15 U Humalog.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • Baseline to study completion (up to 12 weeks)
|
5.0%
2/40 • Number of events 2 • Baseline to study completion (up to 12 weeks)
|
7.3%
3/41 • Number of events 3 • Baseline to study completion (up to 12 weeks)
|
2.5%
1/40 • Number of events 1 • Baseline to study completion (up to 12 weeks)
|
2.4%
1/41 • Number of events 1 • Baseline to study completion (up to 12 weeks)
|
5.0%
2/40 • Number of events 2 • Baseline to study completion (up to 12 weeks)
|
|
General disorders
Injection site reaction
|
2.5%
1/40 • Number of events 1 • Baseline to study completion (up to 12 weeks)
|
2.5%
1/40 • Number of events 1 • Baseline to study completion (up to 12 weeks)
|
14.6%
6/41 • Number of events 6 • Baseline to study completion (up to 12 weeks)
|
0.00%
0/40 • Baseline to study completion (up to 12 weeks)
|
4.9%
2/41 • Number of events 2 • Baseline to study completion (up to 12 weeks)
|
0.00%
0/40 • Baseline to study completion (up to 12 weeks)
|
|
Nervous system disorders
Headache
|
15.0%
6/40 • Number of events 6 • Baseline to study completion (up to 12 weeks)
|
10.0%
4/40 • Number of events 4 • Baseline to study completion (up to 12 weeks)
|
14.6%
6/41 • Number of events 6 • Baseline to study completion (up to 12 weeks)
|
20.0%
8/40 • Number of events 8 • Baseline to study completion (up to 12 weeks)
|
7.3%
3/41 • Number of events 3 • Baseline to study completion (up to 12 weeks)
|
7.5%
3/40 • Number of events 3 • Baseline to study completion (up to 12 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60