A Study of LY900014 Formulations in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Biological: Insulin Lispro; Biological: LY900014

• Registration Number: NCT02317575
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This study evaluated four test formulations of a glucose lowering drug (LY900014) administered by injection under the skin of the abdomen. The study was conducted in healthy people to investigate how the human body handles LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability were documented. The study was to be conducted in two parts (Part A and Part B) to achieve its objectives. Each part of the study was to last for about 11 to 12 weeks, including screening and follow up. Screening was required within 28 days prior to entering into either study Part A or Part B. Part B was not executed because no suitable formulation was identified.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-16
• Study Start: 2015-01
• Primary Completion: 2015-04
• Status Verified: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2020-04-15
• Results First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Results First Posted: 2020-05-13
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Overtly 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 18.5 to 30 kilogram per square meter (kg/m^2), inclusive, at screening
• 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 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study

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Exclusion Criteria

• Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
• Have previously participated or withdrawn from this study
• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A:Insulin Lispro	Insulin Lispro	Reference formulation. 15 U insulin lispro administered SC in one of five periods.
Part A: LY900014 Test D	LY900014	Test Formulation D. Single dose LY900014administered subcutaneously (SC) in one of five periods.
Part A: LY900014 Test A	LY900014	Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
Part A: LY900014 Test B	LY900014	Test Formulation B. Single dose LY900014 administered subcutaneously (SC) in one of five periods.
Part B: LY900014	LY900014	Test formulation selected from Part A. Single dose of LY900014 administered SC in one of four periods.
Part A: LY900014 Test C	LY900014	Test Formulation C. Single dose LY900014administered subcutaneously (SC) in one of five periods.

Primary Outcome Measures

Name	Time	Method
Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast)	30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose

Secondary Outcome Measures

Name	Time	Method
Part B: Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) - Interparticipant Variability	Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose
Part A: Visual Analog Scale (VAS) Score for Injection Site Pain	Predose, 1, 20, 60 minutes postdose and at the end of the clamp procedure	The Visual Analog Scale (VAS) assessed injection site pain on a scale of 0-100 millimeter (mm) range (0 = no pain and 100 worst imaginable pain).
Part B: Total Amount of Glucose Infused (Gtot) Over the Duration of the Clamp - Interparticipant Variability	Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes, then every 20 minutes from 300 to 480 minutes postdose	Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
Part A: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp	Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes postdose	Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic 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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇸🇬 Singapore, Singapore