Healthy
Conditions
Brief summary
The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and the effect of LY900014 on blood sugar levels. For each participant, the study will consist of 3 periods and will last about 51 days.
Interventions
DRUGLY900014
Administered SC
DRUGInsulin Lispro
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
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy native Chinese males or females * Female participants: * Women of child-bearing potential who are abstinent or use effective methods of contraception for the entirety of the study. * Women not of child-bearing potential who are infertile or post-menopausal * Have a body mass index (BMI) of 18 to 28 kilograms per square meter (kg/m²) * Are nonsmokers * Have a fasting plasma glucose value \>71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]) and \<108 mg/dL (6.0 mmol/L)
Exclusion criteria
* Are currently enrolled in a clinical study, or have participated, within the last 30 days, in a clinical study involving an investigational product * Have previously completed or withdrawn from this study or any other study investigating LY900014 * Have known allergies to LY900014 or any components of the formulation * Have a significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data * Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, prior to dosing or during the study. * Have donated blood of more than 400 milliliters (mL) within the previous 6 months of study screening or donated more than 100 mL within the last 30 days. * Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h]) | Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose | PK: Insulin Lispro AUC(0-10h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | Day 1: Predose: -10, -20, -30 minutes; During clamp: every 2.5 to 3 minutes for the first 30 minutes; every 5 minutes for 30 to 120 minutes; every 10 minutes for 120 to 480 minutes and every 20 minutes for 480 to 600 minutes postdose | Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period. |
Countries
China
Participant flow
Pre-assignment details
This was a 3-period crossover study in which participants received a single 7 Unit (U), and a single 15 U subcutaneous (SC) dose of LY900014 in two of three dosing sequences, and 15 U SC dose of Humalog in one of three dosing sequences. There was a washout period of ≥ 3 days between euglycemic clamp visits.
Participants by arm
| Arm | Count |
|---|---|
| Overall Baseline Participants received a single 7 U, and a single 15 U SC dose of LY900014 in 2 of 3 periods and 15 U SC dose of Humalog in 1 of 3 periods. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Overall Baseline |
|---|---|
| Age, Continuous | 27.0 years STANDARD_DEVIATION 3.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 15 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 China | 15 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 1 / 15 | 4 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h])
PK: Insulin Lispro AUC(0-10h)
Time frame: Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose
Population: All participants who received at least one dose of study drug and have evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 7 U LY900014 | Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h]) | 708 picomole * hour per Liter (pmol*h/L) | Geometric Coefficient of Variation 12 |
| 15 U LY900014 | Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h]) | 1580 picomole * hour per Liter (pmol*h/L) | Geometric Coefficient of Variation 11 |
| 15 U Humalog | Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h]) | 1600 picomole * hour per Liter (pmol*h/L) | Geometric Coefficient of Variation 12 |
Secondary
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period.
Time frame: Day 1: Predose: -10, -20, -30 minutes; During clamp: every 2.5 to 3 minutes for the first 30 minutes; every 5 minutes for 30 to 120 minutes; every 10 minutes for 120 to 480 minutes and every 20 minutes for 480 to 600 minutes postdose
Population: All participants who received at least one dose of study drug and had evaluable glucodynamic (GD) data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 7 U LY900014 | Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | 989 milligram per kilogram (mg/kg) | Geometric Coefficient of Variation 35 |
| 15 U LY900014 | Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | 1540 milligram per kilogram (mg/kg) | Geometric Coefficient of Variation 40 |
| 15 U Humalog | Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | 1720 milligram per kilogram (mg/kg) | Geometric Coefficient of Variation 32 |