Phase 1
Completed N=69
Study to Compare 2 Formulations of LY900014 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT03616977 ↗
Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours(h) (AUC [0-10h]) Following Administration of Each Study Arm — 1690; 1710 picomole times hour per liter (pmol*h/L)
Summary
The study involves a comparison of 2 formulations of LY900014, which 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: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours(h) (AUC [0-10h]) Following Administration of Each Study Arm |
1690; 1710 | — |
| SECONDARY Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Study Arm |
1530; 1620 | — |
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
- Had donated blood of more than 450 milliliters (mL) or participated in a clinical trial with similar blood loss 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 (NCT03616977). 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.