A Study to Compare the Effects of a Test and Reference Formulation of LY900014 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY900014

• Registration Number: NCT02752087
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This study of healthy participants evaluated the concentration of a test LY900014 and a reference LY900014 formulation in the bloodstream and how it affected the blood sugar levels. The whole study, including screening, took up to 8 weeks to complete.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-26
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Results First Submitted: 2020-04-20
• Results First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Results First Posted: 2020-05-01
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Female participants who can potentially get pregnant:

  • Must have a negative pregnancy test at the time of screening
  • Agree to continue to use a reliable method of birth control until the end of the study

• Have a body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m²), inclusive, at screening

• Are nonsmokers, have not smoked for at least 2 months before entering the study

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Exclusion Criteria

• Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
• Have known allergies to insulin lispro, related compounds, or any components of the formulation
• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
• Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, before dosing (apart from vitamin/mineral supplements, occasional paracetamol, hormonal contraception, or thyroid-replacement therapy)
• Have used systemic glucocorticoids within 3 months prior to entry into the study
• Have donated blood of more than 450 milliliters (mL) or more in the last 3 months or provided any blood donation within the last month before screening

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
U-95 LY900014 Reference	LY900014	LY900014 reference dose administered via SC injection
U-193 LY900014 Test	LY900014	LY900014 test dose administered via subcutaneous (SC) injection

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])	5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, and 480 minutes post study dose for each treatment	PK: Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC\[0-8 Hours\])

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)	Blood glucose was measured approximately every 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes post dose, and then every 10 minutes until 480 minutes post dose	Gtot is the total glucose infusion over the clamp duration. It is used to measure the study drug action over time as measured by the euglycemic clamp procedure.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇸🇬 Singapore, Singapore