Trial Outcomes & Findings for Study to Compare 2 Formulations of LY900014 in Healthy Participants (NCT NCT03616977)
NCT ID: NCT03616977
Last Updated: 2020-04-30
Results Overview
Pharmacokinetics (PK): Insulin Lispro AUC time zero to 10 hours.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
69 participants
Primary outcome timeframe
Period 1 through 4 Day 1: Predose, 5 minutes(m),10m,15m, 20m, 25m, 30m, 35m, 40m, 45m, 50m, 55m, 60m, 70m, 90m, 120m,150m,180m, 240m, 300m, 360m, 420m, 480m, 540m, and 600m postdose
Results posted on
2020-04-30
Participant Flow
Participant milestones
| Measure |
Sequence 1
Single SC dose of LY900014 U-200 in Periods 1 and 3. Single SC dose of LY900014 U-100 in Periods 2 and 4.
|
Sequence 2
Single SC dose of LY900014 U-100 in Periods 1 and 3. Single SC dose of LY900014 U-200 in Periods 2 and 4.
|
|---|---|---|
|
Period 1
STARTED
|
34
|
35
|
|
Period 1
Received at Least One Dose of Study Drug
|
34
|
34
|
|
Period 1
COMPLETED
|
34
|
34
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
|
Period 2
STARTED
|
34
|
34
|
|
Period 2
COMPLETED
|
34
|
34
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
|
Period 3
STARTED
|
34
|
33
|
|
Period 3
Received Study Drug
|
33
|
32
|
|
Period 3
COMPLETED
|
33
|
32
|
|
Period 3
NOT COMPLETED
|
1
|
1
|
|
Period 4
STARTED
|
33
|
32
|
|
Period 4
COMPLETED
|
33
|
32
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
Single SC dose of LY900014 U-200 in Periods 1 and 3. Single SC dose of LY900014 U-100 in Periods 2 and 4.
|
Sequence 2
Single SC dose of LY900014 U-100 in Periods 1 and 3. Single SC dose of LY900014 U-200 in Periods 2 and 4.
|
|---|---|---|
|
Period 1
Physician Decision
|
0
|
1
|
|
Period 3
Adverse Event
|
1
|
1
|
Baseline Characteristics
Study to Compare 2 Formulations of LY900014 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall
n=68 Participants
Single subcutaneous (SC) dose of LY900014 U-200 in two of four study periods. Single SC dose of LY900014 U-100 in two of four study periods.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 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
|
67 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Period 1 through 4 Day 1: Predose, 5 minutes(m),10m,15m, 20m, 25m, 30m, 35m, 40m, 45m, 50m, 55m, 60m, 70m, 90m, 120m,150m,180m, 240m, 300m, 360m, 420m, 480m, 540m, and 600m postdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Insulin Lispro AUC time zero to 10 hours.
Outcome measures
| Measure |
LY900014 U-100
n=68 Participants
Single SC dose of LY900014 U-100 in two of four study periods.
LY900014 U-100: Administered SC
|
LY900014 U-200
n=68 Participants
Single subcutaneous (SC) dose of LY900014 U-200 in two of four study periods.
LY900014 U-200: Administered SC
|
|---|---|---|
|
Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours(h) (AUC [0-10h]) Following Administration of Each Study Arm
|
1690 picomole times hour per liter (pmol*h/L)
Geometric Coefficient of Variation 18
|
1710 picomole times hour per liter (pmol*h/L)
Geometric Coefficient of Variation 17
|
SECONDARY outcome
Timeframe: Period 1 through 4 Day 1: Predose, every 10 minutes(m) for 30m prior to dosing; During clamp: every 2.5m for 30m; every 5m for 30 to 120m; every 10m for 120 to 480m, and every 20m for 480m to 600m postdosePopulation: All participants who received at least one dose of study drug and have evaluable glucodynamic data.
GD: 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 procedure. During the euglycemic clamp procedure, blood glucose concentrations are held constant after the administration of study treatment by adjusting the exogenous glucose infusion rate.
Outcome measures
| Measure |
LY900014 U-100
n=68 Participants
Single SC dose of LY900014 U-100 in two of four study periods.
LY900014 U-100: Administered SC
|
LY900014 U-200
n=68 Participants
Single subcutaneous (SC) dose of LY900014 U-200 in two of four study periods.
LY900014 U-200: Administered SC
|
|---|---|---|
|
Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Study Arm
|
1530 milligram per kilogram (mg/kg)
Geometric Coefficient of Variation 46
|
1620 milligram per kilogram (mg/kg)
Geometric Coefficient of Variation 45
|
Adverse Events
LY900014 U-100
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
LY900014 U-200
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY900014 U-100
n=68 participants at risk
Single SC dose of LY900014 U-100.
|
LY900014 U-200
n=68 participants at risk
Single SC dose of LY900014 U-200.
|
|---|---|---|
|
General disorders
Catheter site swelling
|
5.9%
4/68 • Number of events 5 • Baseline to end of study (Up to 62 days)
All participants who received at least one dose of study drug.
|
0.00%
0/68 • Baseline to end of study (Up to 62 days)
All participants who received at least one dose of study drug.
|
|
General disorders
Infusion site pain
|
5.9%
4/68 • Number of events 4 • Baseline to end of study (Up to 62 days)
All participants who received at least one dose of study drug.
|
4.4%
3/68 • Number of events 4 • Baseline to end of study (Up to 62 days)
All participants who received at least one dose of study drug.
|
|
General disorders
Infusion site swelling
|
14.7%
10/68 • Number of events 10 • Baseline to end of study (Up to 62 days)
All participants who received at least one dose of study drug.
|
14.7%
10/68 • Number of events 10 • Baseline to end of study (Up to 62 days)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
10.3%
7/68 • Number of events 8 • Baseline to end of study (Up to 62 days)
All participants who received at least one dose of study drug.
|
10.3%
7/68 • Number of events 10 • Baseline to end of study (Up to 62 days)
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place