Phase 1
N=28
A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03232983 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration — 1760; 1800; 2770; 1750 picomole * hour/Liter (pmol * hr/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY900014 (SC) (Drug); LY900014 (IV) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration |
1760; 1800; 2770; 1750 | — |
| SECONDARY Total Amount of Glucose Infused (Gtot) Over Duration of the Clamp Procedure |
1490; 1630; 1730 | — |
Summary
This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh and arm.
The study will be conducted in healthy people to investigate the effect of different injection sites on the amount of insulin lispro in the bloodstream.
Side effects and tolerability will be documented. The study will last for about 10 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
Eligibility Criteria
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)
- 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 6 months prior to entering 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- Have previously participated or withdrawn from this study
- Had blood loss of more than 450 milliliters (mL) within the last 3 months
Data sourced from ClinicalTrials.gov (NCT03232983). 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.