NCT02752087

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2016

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

April 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 years until next milestone

Results Posted

Study results publicly available

May 1, 2020

Completed
Last Updated

May 1, 2020

Status Verified

June 1, 2016

Enrollment Period

1 month

First QC Date

April 22, 2016

Results QC Date

April 20, 2020

Last Update Submit

April 20, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])

    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

Secondary Outcomes (1)

  • 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

Study Arms (2)

U-193 LY900014 Test

EXPERIMENTAL

LY900014 test dose administered via subcutaneous (SC) injection

Drug: LY900014

U-95 LY900014 Reference

ACTIVE COMPARATOR

LY900014 reference dose administered via SC injection

Drug: LY900014

Interventions

LY900014DRUG

Administered SC

Also known as: Ultra-Rapid Lispro
U-193 LY900014 TestU-95 LY900014 Reference

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2016

First Posted

April 26, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 1, 2020

Results First Posted

May 1, 2020

Record last verified: 2016-06

Locations

SG(1)