A Study of Various Formulations of LY900014 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY900014; Drug: Insulin lispro (Humalog)

• Registration Number: NCT02636361
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2015-12-17
• Study First Posted: 2015-12-21
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• 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: 26

Inclusion Criteria

• Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
• Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²) (inclusive) at the time of study screening
• Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
• Are non-smokers or 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
• Have veins suitable for easy blood collection and glucose solution infusion

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Exclusion Criteria

• Have known allergies to insulin lispro or compounds related to these drugs, or any components of the study drug
• Show signs of having an infection or infectious disease at the time of study entry

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY900014 Test B	LY900014	Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods
LY900014 Test A	LY900014	Test formulation B: Single dose of LY900014 formulation administered SC in one of five periods
LY900014 Test C	LY900014	Test formulation C: Single dose of LY900014 formulation administered SC in one of five periods
LY900014 Test D	LY900014	Formulation D: Single dose of LY900014 formulation administered SC in one of five periods
Insulin Lispro	Insulin lispro (Humalog)	Reference formulation: Single dose of lispro administered SC in one of five periods

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro	Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose

Secondary Outcome Measures

Name	Time	Method
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp	Predose, every 2.5 minutes for 30 minutes, then every 5 min until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes.

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