Phase 1
Completed N=42
A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
Source: ClinicalTrials.gov NCT03286751 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) — 649; 656; 1400; 1450 picomole * hour per liter(pmol*/L) — p=0.5495
Summary
This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs are given by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 7 to 12 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) |
649; 656; 1400; 1450; 3050; 3180 | 0.5495 |
| SECONDARY Glucodynamics: Total Amount of Glucose Infused (Gtot) |
1120; 1080; 1970; 1860; 3290; 3030 | 0.5749 |
Eligibility Criteria
Inclusion Criteria
- Healthy male or a female (not pregnant and agreeable to take birth control measures until one month after 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
- 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
- Have previously participated or withdrawn from this study
- Have donated blood or have blood loss of more than 500 mL within the past 3 months
Data sourced from ClinicalTrials.gov (NCT03286751). 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.