Healthy
Conditions
Brief summary
This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.
Interventions
DRUGLY900014
Administered subcutaneously (SC)
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion) * Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²) (inclusive) at the time of study screening * Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study * Are non-smokers or have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study * Have veins suitable for easy blood collection and glucose solution infusion
Exclusion criteria
* Have known allergies to insulin lispro or compounds related to these drugs, or any components of the study drug * Show signs of having an infection or infectious disease at the time of study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro | Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose |
Secondary
| Measure | Time frame |
|---|---|
| Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | Predose, every 2.5 minutes for 30 minutes, then every 5 min until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes. |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All participants who received at least 1 dose of study drug. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Period 4 | Physician Decision | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 40.8 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 24 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Singapore | 24 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 23 | 0 / 24 |
| other Total, other adverse events | 1 / 24 | 0 / 24 | 2 / 24 | 1 / 23 | 3 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 23 | 0 / 24 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro
Time frame: Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose
Population: Participants who received at least 1 dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY900014 Test A | Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro | 245 picomol per hours per liter (pmol*h/L) | Geometric Coefficient of Variation 65 |
| LY900014 Test B | Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro | 295 picomol per hours per liter (pmol*h/L) | Geometric Coefficient of Variation 54 |
| LY900014 Test C | Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro | 251 picomol per hours per liter (pmol*h/L) | Geometric Coefficient of Variation 45 |
| LY900014 Test D | Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro | 253 picomol per hours per liter (pmol*h/L) | Geometric Coefficient of Variation 56 |
| Reference (Insulin Lispro, Humalog) | Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro | 120 picomol per hours per liter (pmol*h/L) | Geometric Coefficient of Variation 101 |
Secondary
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
Time frame: Predose, every 2.5 minutes for 30 minutes, then every 5 min until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes.
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY900014 Test A | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | 84300 milligrams (mg) | Geometric Coefficient of Variation 35 |
| LY900014 Test B | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | 91100 milligrams (mg) | Geometric Coefficient of Variation 35 |
| LY900014 Test C | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | 91300 milligrams (mg) | Geometric Coefficient of Variation 27 |
| LY900014 Test D | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | 88700 milligrams (mg) | Geometric Coefficient of Variation 34 |
| Reference (Insulin Lispro, Humalog) | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | 85400 milligrams (mg) | Geometric Coefficient of Variation 32 |