Healthy
Conditions
Brief summary
This study of healthy participants evaluated the concentration of a test LY900014 and a reference LY900014 formulation in the bloodstream and how it affected the blood sugar levels. The whole study, including screening, took up to 8 weeks to complete.
Interventions
DRUGLY900014
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female participants who can potentially get pregnant: * Must have a negative pregnancy test at the time of screening * Agree to continue to use a reliable method of birth control until the end of the study * Have a body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m²), inclusive, at screening * Are nonsmokers, have not smoked for at least 2 months before entering the study
Exclusion criteria
* Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study * Have known allergies to insulin lispro, related compounds, or any components of the formulation * Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs * Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, before dosing (apart from vitamin/mineral supplements, occasional paracetamol, hormonal contraception, or thyroid-replacement therapy) * Have used systemic glucocorticoids within 3 months prior to entry into the study * Have donated blood of more than 450 milliliters (mL) or more in the last 3 months or provided any blood donation within the last month before screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) | 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 | PK: Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC\[0-8 Hours\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | 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 dose | 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. |
Countries
Singapore
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All 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. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 36.7 years STANDARD_DEVIATION 7.2 |
| 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 | 2 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 24 | 8 / 23 |
| serious Total, serious adverse events | 0 / 24 | 0 / 23 |
Outcome results
Primary
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])
PK: Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC\[0-8 Hours\])
Time frame: 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
Population: All participants who completed at least 1 study period and had measurable insulin lispro concentrations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY900014 Reference | 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 |
| LY900014 Test | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) | 2430 picomole*hour/liter (pmol*h/L) | Geometric Coefficient of Variation 13 |
Secondary
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
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.
Time frame: 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 dose
Population: All participants who completed at least 1 clamp procedure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY900014 Reference | Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | 108,000 milligram (mg) | Geometric Coefficient of Variation 34 |
| LY900014 Test | Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | 117,000 milligram (mg) | Geometric Coefficient of Variation 35 |