NCT02636361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

May 13, 2020

Completed
Last Updated

May 13, 2020

Status Verified

February 1, 2016

Enrollment Period

2 months

First QC Date

December 17, 2015

Results QC Date

April 15, 2020

Last Update Submit

May 12, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (5)

LY900014 Test B

EXPERIMENTAL

Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods

Drug: LY900014

LY900014 Test A

EXPERIMENTAL

Test formulation B: Single dose of LY900014 formulation administered SC in one of five periods

Drug: LY900014

LY900014 Test C

EXPERIMENTAL

Test formulation C: Single dose of LY900014 formulation administered SC in one of five periods

Drug: LY900014

LY900014 Test D

EXPERIMENTAL

Formulation D: Single dose of LY900014 formulation administered SC in one of five periods

Drug: LY900014

Insulin Lispro

ACTIVE COMPARATOR

Reference formulation: Single dose of lispro administered SC in one of five periods

Drug: Insulin lispro (Humalog)

Interventions

LY900014DRUG

Administered subcutaneously (SC)

Also known as: Ultra-Rapid Lispro
LY900014 Test ALY900014 Test BLY900014 Test CLY900014 Test D
Insulin lispro (Humalog)DRUG

Administered SC

Also known as: Humalog, LY275585
Insulin Lispro

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, 117597, Singapore

Location

MeSH Terms

Interventions

Insulin Lispro

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2015

First Posted

December 21, 2015

Study Start

December 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

May 13, 2020

Results First Posted

May 13, 2020

Record last verified: 2016-02

Locations

SG(1)