Phase 1
Completed N=49
A Study to Compare 2 Formulations of LY900014 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT03334448 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Pharmacokinetics (PK): Insulin Lispro Area Under Plasma Concentration Curve Zero to 10 Hours (AUC[0-10]) — 1760; 1550 hours times picomols per milliliter
Summary
The study involves a comparison of a LY900014 U-200 formulation with a LY900014 U-100 formulation. LY900014 is a type of fast acting insulin. Study participants will be administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by injection under the skin. Blood samples will be taken to compare how the body handles the study drugs and how they affect the blood sugar levels. Side effects and tolerability will be documented. The study will last about 4 weeks, not including screening and follow up. Screening is required within 28 days prior to the start of the study and follow up is required at least 2 weeks after the last dose of study drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Insulin Lispro Area Under Plasma Concentration Curve Zero to 10 Hours (AUC[0-10]) |
1760; 1550 | — |
| SECONDARY Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm |
1500; 1410 | — |
Eligibility Criteria
Inclusion Criteria
- 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
- Have veins suitable for easy blood collection and glucose solution infusion
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- Have previously participated or withdrawn from this study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
- Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)
- Smoke more than 10 cigarettes per day
- Are infected with hepatitis B or human immunodeficiency virus (HIV)
- Are taking illegal drugs
Data sourced from ClinicalTrials.gov (NCT03334448). 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.