Phase 1
Completed N=26
A Study of Various Formulations of LY900014 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02636361 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro — 245; 295; 251; 253 picomol per hours per liter (pmol*h/L)
Summary
This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro |
245; 295; 251; 253; 120 | — |
| SECONDARY Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp |
84300; 91100; 91300; 88700; 85400 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
- Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²) (inclusive) at the time of study screening
- Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- Are non-smokers or 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
- Have veins suitable for easy blood collection and glucose solution infusion
Exclusion Criteria
- Have known allergies to insulin lispro or compounds related to these drugs, or any components of the study drug
- Show signs of having an infection or infectious disease at the time of study entry
Data sourced from ClinicalTrials.gov (NCT02636361). 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.