Healthy
Conditions
Brief summary
This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last about 6 to 7 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
Interventions
DRUGLY900014
Administered subcutaneously (SC)
DRUGInsulin Lispro
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion) * Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²), inclusive, at screening * Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study * Are nonsmokers, 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
Exclusion criteria
* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study * Have previously participated or withdrawn from this study * Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study * Had blood loss of more than 450 milliliters (mL) within the last month
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]) | Predose (0), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 210, 240, 300, 330, 360, 420, and 480 minutes, post dose | Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC\[0-8 Hours\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) | 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes postdose, and then every 10 minutes until 480 minutes postdose | Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 or Insulin Lispro by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight. |
Countries
Singapore
Participant flow
Pre-assignment details
The study consisted of two treatment periods, with a minimum of 3 days washout period between each period.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Each participant was administered with 15 U dose of LY900014 and Insulin Lispro. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 39.0 Years STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 32 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 | 32 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 32 | 7 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])
Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC\[0-8 Hours\]).
Time frame: Predose (0), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 210, 240, 300, 330, 360, 420, and 480 minutes, post dose
Population: All randomized participants who receive at least 1 dose of study drug and have measurable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY900014 | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) | 2050 Picomoles*hour/Liter (pmol*h/L) | Geometric Coefficient of Variation 18 |
| Insulin Lispro | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) | 1930 Picomoles*hour/Liter (pmol*h/L) | Geometric Coefficient of Variation 19 |
Secondary
Glucodynamics (GD): Total Amount of Glucose Infused (Gtot)
Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 or Insulin Lispro by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.
Time frame: 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes postdose, and then every 10 minutes until 480 minutes postdose
Population: All randomized participants who received at least one dose of study drug and have evaluable glucodynamic data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY900014 | Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) | 115000 Milligrams (mg) | Geometric Coefficient of Variation 32 |
| Insulin Lispro | Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) | 125000 Milligrams (mg) | Geometric Coefficient of Variation 34 |