Trial Outcomes & Findings for A Study of a New LY900014 Formulation in Healthy Participants (NCT NCT02525744)
NCT ID: NCT02525744
Last Updated: 2020-05-19
Results Overview
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, and 420 minutes per period.
Results posted on
2020-05-19
Participant Flow
Participant milestones
| Measure |
Sequence 1 CBARC
Participants receive single subcutaneous dose:
C: 30 U LY900014 B: 15 U LY900014 A: 7.5 Units (U) LY900014 R: 15 U insulin lispro(Reference) C: 30 U LY900014
with 3 day washout between doses
|
Sequence 2 ACRBA
Participants receive single subcutaneous dose:
A: 7.5 Units (U) LY900014 C: 30 U LY900014 R: 15 U insulin lispro(Reference) B: 15 U LY900014 A: 7.5 Units (U) LY900014
with 3 day washout between doses
|
Sequence 3 BRCAB
Participants receive single subcutaneous dose:
B: 15 U LY900014 R: 15 U insulin lispro(Reference) C: 30 U LY900014 A: 7.5 Units (U) LY900014 B: 15 U LY900014
with 3 day washout between doses
|
Sequence 4 RABCR
Participants receive single subcutaneous dose:
R: 15 U insulin lispro(Reference) A: 7.5 Units (U) LY900014 B: 15 U LY900014 C: 30 U LY900014 R: 15 U insulin lispro(Reference)
with 3 day washout between doses
|
|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
6
|
6
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
6
|
6
|
5
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
5
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Period 2
STARTED
|
6
|
6
|
5
|
6
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
6
|
6
|
5
|
6
|
|
Period 2
COMPLETED
|
6
|
6
|
5
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
6
|
6
|
5
|
6
|
|
Period 3
Received at Least 1 Dose of Study Drug
|
6
|
6
|
5
|
6
|
|
Period 3
COMPLETED
|
6
|
5
|
5
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Period 4
STARTED
|
6
|
5
|
5
|
6
|
|
Period 4
Received at Least 1 Dose of Study Drug
|
6
|
5
|
5
|
6
|
|
Period 4
COMPLETED
|
5
|
5
|
5
|
6
|
|
Period 4
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Period 5
STARTED
|
5
|
5
|
5
|
6
|
|
Period 5
Received at Least 1 Dose of Study Drug
|
4
|
5
|
5
|
6
|
|
Period 5
COMPLETED
|
4
|
5
|
5
|
6
|
|
Period 5
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1 CBARC
Participants receive single subcutaneous dose:
C: 30 U LY900014 B: 15 U LY900014 A: 7.5 Units (U) LY900014 R: 15 U insulin lispro(Reference) C: 30 U LY900014
with 3 day washout between doses
|
Sequence 2 ACRBA
Participants receive single subcutaneous dose:
A: 7.5 Units (U) LY900014 C: 30 U LY900014 R: 15 U insulin lispro(Reference) B: 15 U LY900014 A: 7.5 Units (U) LY900014
with 3 day washout between doses
|
Sequence 3 BRCAB
Participants receive single subcutaneous dose:
B: 15 U LY900014 R: 15 U insulin lispro(Reference) C: 30 U LY900014 A: 7.5 Units (U) LY900014 B: 15 U LY900014
with 3 day washout between doses
|
Sequence 4 RABCR
Participants receive single subcutaneous dose:
R: 15 U insulin lispro(Reference) A: 7.5 Units (U) LY900014 B: 15 U LY900014 C: 30 U LY900014 R: 15 U insulin lispro(Reference)
with 3 day washout between doses
|
|---|---|---|---|---|
|
Period 1
Physician Decision
|
0
|
0
|
1
|
0
|
|
Period 3
Adverse Event
|
0
|
1
|
0
|
0
|
|
Period 4
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Period 5
Physician Decision
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of a New LY900014 Formulation in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall Study
n=23 Participants
All participants who received at least 1 dose of study drug.
|
|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 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
|
22 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
|
1 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
|
23 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
25.23 kilograms per meter squared (kg/m2)
STANDARD_DEVIATION 2.27 • 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, and 420 minutes per period.Population: Participants who received at least 1 dose of study drug and had evaluable PK profile data.
Outcome measures
| Measure |
LY900014 7.5 U
n=27 PK Profiles
Participants receive single subcutaneous dose of 7.5 Units (U) LY900014
|
LY900014 15 U
n=27 PK Profiles
Participants receive single subcutaneous dose of 15 Units (U) LY900014
|
LY900014 30 U
n=28 PK Profiles
Participants receive single subcutaneous dose of 30 U LY900014
|
Insulin Lispro 15 U
n=29 PK Profiles
Participants receive single subcutaneous dose of 15 U insulin lispro (Reference, Humalog)
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) )
|
901 picomol per hour per L (pmol.h/L)
Geometric Coefficient of Variation 17
|
1890 picomol per hour per L (pmol.h/L)
Geometric Coefficient of Variation 19
|
3970 picomol per hour per L (pmol.h/L)
Geometric Coefficient of Variation 15
|
1790 picomol per hour per L (pmol.h/L)
Geometric Coefficient of Variation 14
|
SECONDARY outcome
Timeframe: Every 10 minutes for 30 minutes Predose, Postdose: every 2.5 minutes for 30 minutes, then every 5 minutes until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutesPopulation: Participants who received at least 1 dose of study drug and had evaluable GD profiles.
Outcome measures
| Measure |
LY900014 7.5 U
n=24 Glucodynamic (GD) Profiles
Participants receive single subcutaneous dose of 7.5 Units (U) LY900014
|
LY900014 15 U
n=24 Glucodynamic (GD) Profiles
Participants receive single subcutaneous dose of 15 Units (U) LY900014
|
LY900014 30 U
n=25 Glucodynamic (GD) Profiles
Participants receive single subcutaneous dose of 30 U LY900014
|
Insulin Lispro 15 U
n=27 Glucodynamic (GD) Profiles
Participants receive single subcutaneous dose of 15 U insulin lispro (Reference, Humalog)
|
|---|---|---|---|---|
|
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
|
42900 milligrams (mg)
Geometric Coefficient of Variation 67
|
82200 milligrams (mg)
Geometric Coefficient of Variation 41
|
122000 milligrams (mg)
Geometric Coefficient of Variation 35
|
70700 milligrams (mg)
Geometric Coefficient of Variation 48
|
Adverse Events
15 U Insulin Lispro (Reference,Humalog)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY900014 7.5 U
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY900014 15 U
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
LY900014 30 U
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
15 U Insulin Lispro (Reference,Humalog)
n=23 participants at risk
Participants received single subcutaneous dose of 15 U insulin lispro (Reference, Humalog)
|
LY900014 7.5 U
n=22 participants at risk
Participants received single subcutaneous dose of 7.5 U LY900014
|
LY900014 15 U
n=22 participants at risk
Participants received single subcutaneous dose of 15 U LY900014
|
LY900014 30 U
n=23 participants at risk
Participants received single subcutaneous dose of 30 U LY900014
|
|---|---|---|---|---|
|
General disorders
Catheter site related reaction
|
0.00%
0/23
|
9.1%
2/22 • Number of events 2
|
9.1%
2/22 • Number of events 2
|
0.00%
0/23
|
|
General disorders
Infusion site haematoma
|
4.3%
1/23 • Number of events 1
|
0.00%
0/22
|
0.00%
0/22
|
8.7%
2/23 • Number of events 2
|
|
General disorders
Infusion site pain
|
13.0%
3/23 • Number of events 3
|
0.00%
0/22
|
9.1%
2/22 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Infusion site reaction
|
0.00%
0/23
|
4.5%
1/22 • Number of events 1
|
9.1%
2/22 • Number of events 2
|
0.00%
0/23
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place