Trial Outcomes & Findings for A Study to Compare 2 Formulations of LY900014 in Healthy Participants (NCT NCT03334448)
NCT ID: NCT03334448
Last Updated: 2020-05-01
Results Overview
Insulin Lispro AUC From Time Zero to 10 hours post dose (AUC\[0-10h\])
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
49 participants
Primary outcome timeframe
Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn, 45 mn, 50mn, 55 mn, 60mn, 70mn,90mn,120mn,150mn,180mn, 240mn,300mn,360mn,320mn, 480mn, 540mn, and 600mn (10 hours)
Results posted on
2020-05-01
Participant Flow
Participant milestones
| Measure |
Sequence 1
Single subcutaneous (SC) dose sequences with 3 day washout between doses:
A. LY900014 U-200 B. LY900014 U-100 C. LY900014 U-200 D. LY900014 U-100
|
Sequence 2
Single subcutaneous (SC) dose sequences with 3 day washout between doses:
A. LY900014 U-100 B. LY900014 U-200 C. LY900014 U-100 D. LY900014 U-200
|
Sequence 3
Single subcutaneous (SC) dose sequences with 3 day washout between doses:
A. LY900014 U-200 B. LY900014 U-100 C. LY900014 U-100 D. LY900014 U-200
|
Sequence 4
Single subcutaneous (SC) dose sequences with 3 day washout between doses:
A. LY900014 U-100 B. LY900014 U-200 C. LY900014 U-200 D. LY900014 U-100
|
|---|---|---|---|---|
|
Period 1
STARTED
|
12
|
12
|
13
|
12
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
12
|
12
|
13
|
12
|
|
Period 1
COMPLETED
|
12
|
12
|
13
|
12
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout
STARTED
|
12
|
11
|
13
|
12
|
|
Washout
COMPLETED
|
12
|
11
|
13
|
11
|
|
Washout
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Period 2
STARTED
|
12
|
12
|
13
|
12
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
12
|
12
|
13
|
12
|
|
Period 2
COMPLETED
|
12
|
12
|
13
|
12
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
12
|
11
|
13
|
12
|
|
Period 3
Received at Least 1 Dose of Study Drug
|
12
|
11
|
13
|
12
|
|
Period 3
COMPLETED
|
12
|
11
|
13
|
12
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
12
|
11
|
13
|
11
|
|
Period 4
Received at Least 1 Dose of Study Drug
|
12
|
11
|
13
|
11
|
|
Period 4
COMPLETED
|
12
|
11
|
13
|
11
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
Single subcutaneous (SC) dose sequences with 3 day washout between doses:
A. LY900014 U-200 B. LY900014 U-100 C. LY900014 U-200 D. LY900014 U-100
|
Sequence 2
Single subcutaneous (SC) dose sequences with 3 day washout between doses:
A. LY900014 U-100 B. LY900014 U-200 C. LY900014 U-100 D. LY900014 U-200
|
Sequence 3
Single subcutaneous (SC) dose sequences with 3 day washout between doses:
A. LY900014 U-200 B. LY900014 U-100 C. LY900014 U-100 D. LY900014 U-200
|
Sequence 4
Single subcutaneous (SC) dose sequences with 3 day washout between doses:
A. LY900014 U-100 B. LY900014 U-200 C. LY900014 U-200 D. LY900014 U-100
|
|---|---|---|---|---|
|
Washout
Personal Reason
|
0
|
1
|
0
|
0
|
|
Washout
Protocol Violation
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Compare 2 Formulations of LY900014 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall
n=49 Participants
All randomized participants who received at least 1 dose of study drug
|
|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 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
|
47 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
|
2 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
|
49 Participants
n=5 Participants
|
|
Weight
|
72.16 kilograms (kg)
STANDARD_DEVIATION 10.97 • n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn, 45 mn, 50mn, 55 mn, 60mn, 70mn,90mn,120mn,150mn,180mn, 240mn,300mn,360mn,320mn, 480mn, 540mn, and 600mn (10 hours)Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
Insulin Lispro AUC From Time Zero to 10 hours post dose (AUC\[0-10h\])
Outcome measures
| Measure |
LY900014-U100
n=49 Participants
Single SC dose of LY900014 U-100 containing 15 units of insulin lispro in two of four study periods
|
LY900014-U200
n=49 Participants
Single subcutaneous (SC) dose of LY900014 U-200 containing 15 units of insulin lispro (Humalog) in two of four study periods
|
|---|---|---|
|
Pharmacokinetics (PK): Insulin Lispro Area Under Plasma Concentration Curve Zero to 10 Hours (AUC[0-10])
|
1760 hours times picomols per milliliter
Geometric Coefficient of Variation 19
|
1550 hours times picomols per milliliter
Geometric Coefficient of Variation 42
|
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.
Glucodynamics: 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.
Outcome measures
| Measure |
LY900014-U100
n=49 Participants
Single SC dose of LY900014 U-100 containing 15 units of insulin lispro in two of four study periods
|
LY900014-U200
n=49 Participants
Single subcutaneous (SC) dose of LY900014 U-200 containing 15 units of insulin lispro (Humalog) in two of four study periods
|
|---|---|---|
|
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm
|
1500 milligrams per kilogram (mg/kg)
Geometric Coefficient of Variation 47
|
1410 milligrams per kilogram (mg/kg)
Geometric Coefficient of Variation 55
|
Adverse Events
LY900014-U100
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
LY900014-U200
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY900014-U100
n=49 participants at risk
Single SC dose of LY900014 U-100 containing 15 units of insulin lispro in two of four study periods
|
LY900014-U200
n=49 participants at risk
Single subcutaneous (SC) dose of LY900014 U-200 containing 15 units of insulin lispro (Humalog) in two of four study periods
|
|---|---|---|
|
General disorders
Catheter site bruise
|
12.2%
6/49 • Number of events 8 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
12.2%
6/49 • Number of events 9 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site pain
|
8.2%
4/49 • Number of events 5 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site swelling
|
12.2%
6/49 • Number of events 9 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
4.1%
2/49 • Number of events 3 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Infusion site bruising
|
6.1%
3/49 • Number of events 3 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
12.2%
6/49 • Number of events 6 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Infusion site pain
|
12.2%
6/49 • Number of events 6 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
20.4%
10/49 • Number of events 12 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Infusion site swelling
|
10.2%
5/49 • Number of events 6 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
8.2%
4/49 • Number of events 4 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site reaction
|
46.9%
23/49 • Number of events 30 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
32.7%
16/49 • Number of events 18 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
6.1%
3/49 • Number of events 3 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
6.1%
3/49 • Number of events 4 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/49 • Number of events 1 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
1/49 • Number of events 1 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up to 15 months
All participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60