Phase 1
Completed N=24
A Study to Compare the Effects of a Test and Reference Formulation of LY900014 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02752087 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) — 2440; 2430 picomole*hour/liter (pmol*h/L)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) |
2440; 2430 | — |
| SECONDARY Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) |
108,000; 117,000 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02752087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.