Trial Outcomes & Findings for A Study to Compare the Effects of a Test and Reference Formulation of LY900014 in Healthy Participants (NCT NCT02752087)
NCT ID: NCT02752087
Last Updated: 2020-05-01
Results Overview
PK: Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC\[0-8 Hours\])
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, and 480 minutes post study dose for each treatment
Results posted on
2020-05-01
Participant Flow
This was a four-period crossover study of U-193 LY900014 test formulation and U-95 LY900014 reference formulation with a minimum of 3 days between dosing.
Participant milestones
| Measure |
LY900014 Test/Reference/Test/Reference
U-193 LY900014 test formulation administered once subcutaneously (SC) in Study Periods 1 and 3. U-95 LY900014 reference formulation administered once SC in Study Periods 2 and 4.
|
LY900014 Reference/Test/Reference/Test
U-95 LY900014 reference formulation administered once SC in study periods 1 and 3. U-193 LY900014 test formulation administered once SC in study periods 2 and 4.
|
|---|---|---|
|
Study Period 1
STARTED
|
12
|
12
|
|
Study Period 1
Received Study Drug
|
12
|
12
|
|
Study Period 1
COMPLETED
|
12
|
12
|
|
Study Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
11
|
12
|
|
Washout
COMPLETED
|
11
|
12
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Study Period 2
STARTED
|
11
|
12
|
|
Study Period 2
Received Study Drug
|
11
|
12
|
|
Study Period 2
COMPLETED
|
11
|
12
|
|
Study Period 2
NOT COMPLETED
|
0
|
0
|
|
Study Period 3
STARTED
|
11
|
12
|
|
Study Period 3
Received Study Drug
|
11
|
12
|
|
Study Period 3
COMPLETED
|
11
|
12
|
|
Study Period 3
NOT COMPLETED
|
0
|
0
|
|
Study Period 4
STARTED
|
11
|
12
|
|
Study Period 4
Received Study Drug
|
11
|
12
|
|
Study Period 4
COMPLETED
|
11
|
12
|
|
Study Period 4
NOT COMPLETED
|
0
|
0
|
|
Follow-up
STARTED
|
11
|
12
|
|
Follow-up
COMPLETED
|
11
|
12
|
|
Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
LY900014 Test/Reference/Test/Reference
U-193 LY900014 test formulation administered once subcutaneously (SC) in Study Periods 1 and 3. U-95 LY900014 reference formulation administered once SC in Study Periods 2 and 4.
|
LY900014 Reference/Test/Reference/Test
U-95 LY900014 reference formulation administered once SC in study periods 1 and 3. U-193 LY900014 test formulation administered once SC in study periods 2 and 4.
|
|---|---|---|
|
Washout
Physician Decision
|
1
|
0
|
Baseline Characteristics
A Study to Compare the Effects of a Test and Reference Formulation of LY900014 in Healthy Participants
Baseline characteristics by cohort
| Measure |
All Participants
n=24 Participants
U-193 LY900014 test formulation administered once SC in 2 of 4 study periods. U-95 LY900014 reference formulation administered once SC in 2 of 4 study periods.
|
|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 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: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, and 480 minutes post study dose for each treatmentPopulation: All participants who completed at least 1 study period and had measurable insulin lispro concentrations.
PK: Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC\[0-8 Hours\])
Outcome measures
| Measure |
LY900014 Reference
n=46 Number of observations
U-95 LY900014 reference formulation administered once SC in 2 of 4 study periods.
|
LY900014 Test
n=47 Number of observations
U-193 LY900014 test formulation administered once SC in 2 of 4 study periods.
|
|---|---|---|
|
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])
|
2440 picomole*hour/liter (pmol*h/L)
Geometric Coefficient of Variation 13
|
2430 picomole*hour/liter (pmol*h/L)
Geometric Coefficient of Variation 13
|
SECONDARY outcome
Timeframe: Blood glucose was measured approximately every 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes post dose, and then every 10 minutes until 480 minutes post dosePopulation: All participants who completed at least 1 clamp procedure.
Gtot is the total glucose infusion over the clamp duration. It is used to measure the study drug action over time as measured by the euglycemic clamp procedure.
Outcome measures
| Measure |
LY900014 Reference
n=46 Number of observations
U-95 LY900014 reference formulation administered once SC in 2 of 4 study periods.
|
LY900014 Test
n=47 Number of observations
U-193 LY900014 test formulation administered once SC in 2 of 4 study periods.
|
|---|---|---|
|
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
|
108,000 milligram (mg)
Geometric Coefficient of Variation 34
|
117,000 milligram (mg)
Geometric Coefficient of Variation 35
|
Adverse Events
LY900014 Test
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
LY900014 Reference
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY900014 Test
n=24 participants at risk
U-193 LY900014 test formulation administered once SC in 2 of 4 study periods.
|
LY900014 Reference
n=23 participants at risk
U-95 LY900014 reference formulation administered once SC in 2 of 4 study periods.
|
|---|---|---|
|
General disorders
Infusion site erythema
|
8.3%
2/24 • Number of events 2
|
0.00%
0/23
|
|
General disorders
Infusion site swelling
|
12.5%
3/24 • Number of events 5
|
13.0%
3/23 • Number of events 3
|
|
General disorders
Injection site erythema
|
4.2%
1/24 • Number of events 1
|
8.7%
2/23 • Number of events 3
|
|
General disorders
Injection site pain
|
8.3%
2/24 • Number of events 2
|
13.0%
3/23 • Number of events 3
|
|
General disorders
Vessel puncture site bruise
|
20.8%
5/24 • Number of events 9
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Vessel puncture site rash
|
8.3%
2/24 • Number of events 5
|
4.3%
1/23 • Number of events 2
|
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