Trial Outcomes & Findings for A Study of LY900014 Formulations in Healthy Participants (NCT NCT02317575)
NCT ID: NCT02317575
Last Updated: 2020-05-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose
Results posted on
2020-05-13
Participant Flow
Part B was not executed and no data were collected.
Part A was a 5-period crossover study of four LY900014 formulations (Tests A, B, C, and D) and insulin lispro (Reference (R)). A minimum of 3 days washout between each period.
Participant milestones
| Measure |
Part A Sequence 1, CDABR
Period 1: LY900014 Test C, Period 2: LY900014 Test D, Period 3: LY900014 Test A, Period 4: LY900014 Test B, Period 5: Reference (R) = insulin lispro
|
Part A Sequence 2, ABDRC
Period 1: LY900014 Test A, Period 2: LY900014 Test B, Period 3: LY900014 Test D, Period 4: Reference (R) = insulin lispro, Period 5: LY900014 Test C
|
Part A Sequence 3, BCRAD
Period 1: LY900014 Test B, Period 2: LY900014 Test C, Period 3: Reference (R) = insulin lispro, Period 4: LY900014 Test A, Period 5: LY900014 Test D
|
Part A Sequence 4, DRBCA
Period 1: LY900014 Test D, Period 2: Reference (R) = insulin lispro, Period 3: LY900014 Test B, Period 4: LY900014 Test C, Period 5: LY900014 Test A
|
Part A Sequence 5, RACDB
Period 1: Reference (R) = insulin lispro, Period 2: LY900014 Test A, Period 3: LY900014 Test C, Period 4: LY900014 Test D, Period 5: LY900014 Test B
|
|---|---|---|---|---|---|
|
Period 1
STARTED
|
5
|
6
|
6
|
6
|
6
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
5
|
5
|
6
|
6
|
6
|
|
Period 1
COMPLETED
|
4
|
5
|
6
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
|
Period 2
STARTED
|
4
|
5
|
6
|
6
|
6
|
|
Period 2
COMPLETED
|
4
|
5
|
6
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
4
|
5
|
6
|
6
|
6
|
|
Period 3
COMPLETED
|
4
|
5
|
6
|
6
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
4
|
5
|
6
|
6
|
6
|
|
Period 4
COMPLETED
|
4
|
5
|
6
|
6
|
6
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 5
STARTED
|
4
|
5
|
6
|
6
|
6
|
|
Period 5
COMPLETED
|
4
|
5
|
6
|
6
|
6
|
|
Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A Sequence 1, CDABR
Period 1: LY900014 Test C, Period 2: LY900014 Test D, Period 3: LY900014 Test A, Period 4: LY900014 Test B, Period 5: Reference (R) = insulin lispro
|
Part A Sequence 2, ABDRC
Period 1: LY900014 Test A, Period 2: LY900014 Test B, Period 3: LY900014 Test D, Period 4: Reference (R) = insulin lispro, Period 5: LY900014 Test C
|
Part A Sequence 3, BCRAD
Period 1: LY900014 Test B, Period 2: LY900014 Test C, Period 3: Reference (R) = insulin lispro, Period 4: LY900014 Test A, Period 5: LY900014 Test D
|
Part A Sequence 4, DRBCA
Period 1: LY900014 Test D, Period 2: Reference (R) = insulin lispro, Period 3: LY900014 Test B, Period 4: LY900014 Test C, Period 5: LY900014 Test A
|
Part A Sequence 5, RACDB
Period 1: Reference (R) = insulin lispro, Period 2: LY900014 Test A, Period 3: LY900014 Test C, Period 4: LY900014 Test D, Period 5: LY900014 Test B
|
|---|---|---|---|---|---|
|
Period 1
Difficulty with venous cannulation
|
0
|
1
|
0
|
0
|
0
|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY900014 Formulations in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall Study
n=28 Participants
Participants were administered LY900014 SC Tests A, B, C, and D, with that of 15 U of insulin lispro alone (Reference) in healthy subjects.
|
|---|---|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 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
|
27 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
|
28 Participants
n=5 Participants
|
|
Weight
|
72.60 kilograms (kg)
STANDARD_DEVIATION 9.07 • n=5 Participants
|
|
Body Mass Index (BMI)
|
24.43 kilogram per meter squared (kg/m²)
STANDARD_DEVIATION 2.21 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdosePopulation: All participants who received at least 1 dose of study drug and completed the dose sequence.
Outcome measures
| Measure |
Part A: Formulation A, LY900014
n=27 Participants
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Formulation B, LY900014
n=27 Participants
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Formulation C, LY900014
n=28 Participants
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Formulation D, LY900014
n=27 Participants
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Reference
n=27 Participants
15 U of insulin lispro administered subcutaneously (SC) in one of five periods
|
|---|---|---|---|---|---|
|
Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast)
|
1720 picomol times hour per liter (pmol*h/L)
Geometric Coefficient of Variation 20
|
1740 picomol times hour per liter (pmol*h/L)
Geometric Coefficient of Variation 17
|
1810 picomol times hour per liter (pmol*h/L)
Geometric Coefficient of Variation 21
|
1750 picomol times hour per liter (pmol*h/L)
Geometric Coefficient of Variation 19
|
1690 picomol times hour per liter (pmol*h/L)
Geometric Coefficient of Variation 19
|
SECONDARY outcome
Timeframe: Predose, 1, 20, 60 minutes postdose and at the end of the clamp procedurePopulation: All participants who received at least 1 dose of study drug.
The Visual Analog Scale (VAS) assessed injection site pain on a scale of 0-100 millimeter (mm) range (0 = no pain and 100 worst imaginable pain).
Outcome measures
| Measure |
Part A: Formulation A, LY900014
n=27 Participants
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Formulation B, LY900014
n=27 Participants
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Formulation C, LY900014
n=28 Participants
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Formulation D, LY900014
n=27 Participants
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Reference
n=27 Participants
15 U of insulin lispro administered subcutaneously (SC) in one of five periods
|
|---|---|---|---|---|---|
|
Part A: Visual Analog Scale (VAS) Score for Injection Site Pain
1 minute
|
0.1 millimeter (mm)
Standard Deviation 0.6
|
2.1 millimeter (mm)
Standard Deviation 6.5
|
1.8 millimeter (mm)
Standard Deviation 4.8
|
1.3 millimeter (mm)
Standard Deviation 4.7
|
0.5 millimeter (mm)
Standard Deviation 1.9
|
|
Part A: Visual Analog Scale (VAS) Score for Injection Site Pain
20 minutes
|
0 millimeter (mm)
Standard Deviation 0
|
0 millimeter (mm)
Standard Deviation 0
|
0 millimeter (mm)
Standard Deviation 0
|
2.0 millimeter (mm)
Standard Deviation 9.6
|
0 millimeter (mm)
Standard Deviation 0
|
|
Part A: Visual Analog Scale (VAS) Score for Injection Site Pain
60 minutes
|
0 millimeter (mm)
Standard Deviation 0
|
0 millimeter (mm)
Standard Deviation 0
|
0 millimeter (mm)
Standard Deviation 0
|
1.1 millimeter (mm)
Standard Deviation 6.0
|
0 millimeter (mm)
Standard Deviation 0
|
|
Part A: Visual Analog Scale (VAS) Score for Injection Site Pain
End of clamp
|
0 millimeter (mm)
Standard Deviation 0
|
0 millimeter (mm)
Standard Deviation 0
|
0 millimeter (mm)
Standard Deviation 0
|
0 millimeter (mm)
Standard Deviation 0.2
|
0 millimeter (mm)
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes postdosePopulation: All participants who received at least 1 dose of study drug and completed the dose sequence.
Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
Outcome measures
| Measure |
Part A: Formulation A, LY900014
n=27 Participants
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Formulation B, LY900014
n=27 Participants
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Formulation C, LY900014
n=28 Participants
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Formulation D, LY900014
n=27 Participants
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Reference
n=27 Participants
15 U of insulin lispro administered subcutaneously (SC) in one of five periods
|
|---|---|---|---|---|---|
|
Part A: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
|
78372 milligram (mg)
Geometric Coefficient of Variation 29
|
81776 milligram (mg)
Geometric Coefficient of Variation 41
|
82365 milligram (mg)
Geometric Coefficient of Variation 35
|
80186 milligram (mg)
Geometric Coefficient of Variation 34
|
75571 milligram (mg)
Geometric Coefficient of Variation 37
|
SECONDARY outcome
Timeframe: Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes, then every 20 minutes from 300 to 480 minutes postdosePopulation: Zero participants were analyzed as Part B was not executed.
Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdosePopulation: Zero participants were analyzed as Part B was not executed.
Outcome measures
Outcome data not reported
Adverse Events
Part A: Formulation A, LY900014
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: Formulation B, LY900014
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: Forumulation C, LY900014
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Forumulation D, LY900014
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A: Reference
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 |
Part A: Formulation A, LY900014
n=27 participants at risk
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Formulation B, LY900014
n=27 participants at risk
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Forumulation C, LY900014
n=28 participants at risk
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Forumulation D, LY900014
n=27 participants at risk
Single dose LY900014 administered subcutaneously (SC) in one of five periods
|
Part A: Reference
n=27 participants at risk
15 U insulin lispro administered subcutaneously (SC)
|
|---|---|---|---|---|---|
|
General disorders
Catheter site related reaction
|
18.5%
5/27 • Number of events 5
|
18.5%
5/27 • Number of events 5
|
7.1%
2/28 • Number of events 2
|
22.2%
6/27 • Number of events 6
|
7.4%
2/27 • 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
Restriction type: GT60