Trial Outcomes & Findings for A Study of Various Formulations of LY900014 in Healthy Participants (NCT NCT02636361)
NCT ID: NCT02636361
Last Updated: 2020-05-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose
Results posted on
2020-05-13
Participant Flow
Participant milestones
| Measure |
Sequence 1 BDCAR
B = LY900014 Test B, D, LY900014 Test D, C = LY900014 Test C, A = LY900014 Test A, R = Reference, insulin lispro (Humalog)
|
Sequence 2 ADCRB
A = LY900014 Test A, D=LY900014 Test D, C = LY900014 Test C, R = Reference, insulin lispro (Humalog), B = LY900014 Test B
|
Sequence 3 ADRCB
A = LY900014 Test A, D=LY900014 Test D,R = Reference, insulin lispro (Humalog), C = LY900014 Test C, B = LY900014 Test B
|
Sequence 4 BRDAC
B = LY900014 Test B,R = Reference, insulin lispro (Humalog),D=LY900014 Test D, A = LY900014 Test A,C = LY900014 Test C
|
Sequence 5 RADCB
R = Reference, insulin lispro (Humalog)A = LY900014 Test A, D=LY900014 Test D, C = LY900014 Test C, B = LY900014 Test B
|
|---|---|---|---|---|---|
|
Period 1
STARTED
|
5
|
6
|
5
|
5
|
5
|
|
Period 1
Received at Least One Dose of Study Drug
|
5
|
5
|
5
|
5
|
4
|
|
Period 1
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
1
|
|
Period 2
STARTED
|
5
|
5
|
5
|
5
|
4
|
|
Period 2
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
5
|
5
|
5
|
5
|
4
|
|
Period 3
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
5
|
5
|
5
|
5
|
4
|
|
Period 4
COMPLETED
|
5
|
5
|
5
|
4
|
4
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
|
Period 5
STARTED
|
5
|
5
|
5
|
4
|
4
|
|
Period 5
COMPLETED
|
5
|
5
|
5
|
4
|
4
|
|
Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1 BDCAR
B = LY900014 Test B, D, LY900014 Test D, C = LY900014 Test C, A = LY900014 Test A, R = Reference, insulin lispro (Humalog)
|
Sequence 2 ADCRB
A = LY900014 Test A, D=LY900014 Test D, C = LY900014 Test C, R = Reference, insulin lispro (Humalog), B = LY900014 Test B
|
Sequence 3 ADRCB
A = LY900014 Test A, D=LY900014 Test D,R = Reference, insulin lispro (Humalog), C = LY900014 Test C, B = LY900014 Test B
|
Sequence 4 BRDAC
B = LY900014 Test B,R = Reference, insulin lispro (Humalog),D=LY900014 Test D, A = LY900014 Test A,C = LY900014 Test C
|
Sequence 5 RADCB
R = Reference, insulin lispro (Humalog)A = LY900014 Test A, D=LY900014 Test D, C = LY900014 Test C, B = LY900014 Test B
|
|---|---|---|---|---|---|
|
Period 4
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Various Formulations of LY900014 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall Study
n=24 Participants
All participants who received at least 1 dose of study drug.
|
|---|---|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
24 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
|
0 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
Singapore
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdosePopulation: Participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
LY900014 Test A
n=24 Participants
LY900014 Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
|
LY900014 Test B
n=24 Participants
LY900014 Test Formulation B. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
|
LY900014 Test C
n=23 Participants
LY900014 Test Formulation C. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
|
LY900014 Test D
n=24 Participants
LY900014 Test Formulation D. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
|
Reference (Insulin Lispro, Humalog)
n=24 Participants
A single dose of Reference (insulin lispro, Humalog) administered SC in one of five periods
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro
|
245 picomol per hours per liter (pmol*h/L)
Geometric Coefficient of Variation 65
|
295 picomol per hours per liter (pmol*h/L)
Geometric Coefficient of Variation 54
|
251 picomol per hours per liter (pmol*h/L)
Geometric Coefficient of Variation 45
|
253 picomol per hours per liter (pmol*h/L)
Geometric Coefficient of Variation 56
|
120 picomol per hours per liter (pmol*h/L)
Geometric Coefficient of Variation 101
|
SECONDARY outcome
Timeframe: Predose, every 2.5 minutes for 30 minutes, then every 5 min until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes.Population: All participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
LY900014 Test A
n=24 Participants
LY900014 Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
|
LY900014 Test B
n=24 Participants
LY900014 Test Formulation B. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
|
LY900014 Test C
n=24 Participants
LY900014 Test Formulation C. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
|
LY900014 Test D
n=24 Participants
LY900014 Test Formulation D. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
|
Reference (Insulin Lispro, Humalog)
n=24 Participants
A single dose of Reference (insulin lispro, Humalog) administered SC in one of five periods
|
|---|---|---|---|---|---|
|
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
|
84300 milligrams (mg)
Geometric Coefficient of Variation 35
|
91100 milligrams (mg)
Geometric Coefficient of Variation 35
|
91300 milligrams (mg)
Geometric Coefficient of Variation 27
|
88700 milligrams (mg)
Geometric Coefficient of Variation 34
|
85400 milligrams (mg)
Geometric Coefficient of Variation 32
|
Adverse Events
Reference (Insulin Lispro, Humalog)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY900014 Test A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LY900014 Test B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LY900014 Test C
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY900014 Test D
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reference (Insulin Lispro, Humalog)
n=24 participants at risk
Reference formulation: Single dose of lispro administered SC in one of five periods
|
LY900014 Test A
n=24 participants at risk
Test formulation A: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods
|
LY900014 Test B
n=24 participants at risk
Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods
|
LY900014 Test C
n=23 participants at risk
Test formulation C: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods
|
LY900014 Test D
n=24 participants at risk
Test formulation D: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods
|
|---|---|---|---|---|---|
|
General disorders
Catheter site related reaction
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
12.5%
3/24 • Number of events 4
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60