A Study of LY900014 Formulations in Healthy Participants

May 12, 2020 updated by: Eli Lilly and Company

Safety, Tolerability, Pharmacokinetics and Glucodynamics of Multiple Insulin Lispro (LY900014) Formulations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117597
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: LY900014 Test A
Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
Biological: LY900014
Administered SC
Other Names:
  • Ultra-Rapid Lispro
Experimental: Part A:Insulin Lispro
Reference formulation. 15 U insulin lispro administered SC in one of five periods.
Biological: Insulin Lispro
Administered SC
Other Names:
  • LY275585
Experimental: Part A: LY900014 Test B
Test Formulation B. Single dose LY900014 administered subcutaneously (SC) in one of five periods.
Biological: LY900014
Administered SC
Other Names:
  • Ultra-Rapid Lispro
Experimental: Part A: LY900014 Test C
Test Formulation C. Single dose LY900014administered subcutaneously (SC) in one of five periods.
Biological: LY900014
Administered SC
Other Names:
  • Ultra-Rapid Lispro
Experimental: Part A: LY900014 Test D
Test Formulation D. Single dose LY900014administered subcutaneously (SC) in one of five periods.
Biological: LY900014
Administered SC
Other Names:
  • Ultra-Rapid Lispro
Experimental: Part B: LY900014
Test formulation selected from Part A. Single dose of LY900014 administered SC in one of four periods.
Biological: LY900014
Administered SC
Other Names:
  • Ultra-Rapid Lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast)
Time Frame: 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
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

Outcome Measure
Measure Description
Time Frame
Part A: Visual Analog Scale (VAS) Score for Injection Site Pain
Time Frame: 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).
Predose, 1, 20, 60 minutes postdose and at the end of the clamp procedure
Part A: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
Time Frame: 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.
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
Part B: Total Amount of Glucose Infused (Gtot) Over the Duration of the Clamp - Interparticipant Variability
Time Frame: 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.
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
Part B: Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) - Interparticipant Variability
Time Frame: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose
Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 16, 2014

Study Record Updates

Last Update Posted (Actual)

May 13, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15645
  • I8B-FW-ITRA (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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