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 for about 8 to 9 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
Interventions
DRUGLY900014
Administered 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) * Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m\^2), 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days or any other type of medical research judged to be incompatible with this study * Have previously participated or withdrawn from this study * Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) ) | 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period. |
Secondary
| Measure | Time frame |
|---|---|
| Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | Every 10 minutes for 30 minutes Predose, Postdose: every 2.5 minutes for 30 minutes, then every 5 minutes 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. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period 1 | Physician Decision | 0 | 0 | 1 | 0 |
| Period 3 | Adverse Event | 0 | 1 | 0 | 0 |
| Period 4 | Withdrawal by Subject | 1 | 0 | 0 | 0 |
| Period 5 | Physician Decision | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 35.9 years STANDARD_DEVIATION 9.7 |
| Body Mass Index (BMI) | 25.23 kilograms per meter squared (kg/m2) STANDARD_DEVIATION 2.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 22 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 | 1 Participants |
| Region of Enrollment Singapore | 23 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 3 / 23 | 3 / 22 | 6 / 22 | 2 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 | 0 / 22 | 0 / 23 |
Outcome results
Primary
Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) )
Time frame: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period.
Population: Participants who received at least 1 dose of study drug and had evaluable PK profile data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY900014 7.5 U | Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) ) | 901 picomol per hour per L (pmol.h/L) | Geometric Coefficient of Variation 17 |
| LY900014 15 U | Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) ) | 1890 picomol per hour per L (pmol.h/L) | Geometric Coefficient of Variation 19 |
| LY900014 30 U | Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) ) | 3970 picomol per hour per L (pmol.h/L) | Geometric Coefficient of Variation 15 |
| Insulin Lispro 15 U | Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) ) | 1790 picomol per hour per L (pmol.h/L) | Geometric Coefficient of Variation 14 |
Secondary
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
Time frame: Every 10 minutes for 30 minutes Predose, Postdose: every 2.5 minutes for 30 minutes, then every 5 minutes until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes
Population: Participants who received at least 1 dose of study drug and had evaluable GD profiles.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY900014 7.5 U | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | 42900 milligrams (mg) | Geometric Coefficient of Variation 67 |
| LY900014 15 U | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | 82200 milligrams (mg) | Geometric Coefficient of Variation 41 |
| LY900014 30 U | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | 122000 milligrams (mg) | Geometric Coefficient of Variation 35 |
| Insulin Lispro 15 U | Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp | 70700 milligrams (mg) | Geometric Coefficient of Variation 48 |