NCT03334448

Brief Summary

The study involves a comparison of a LY900014 U-200 formulation with a LY900014 U-100 formulation. LY900014 is a type of fast acting insulin. Study participants will be administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by injection under the skin. Blood samples will be taken to compare how the body handles the study drugs and how they affect the blood sugar levels. Side effects and tolerability will be documented. The study will last about 4 weeks, not including screening and follow up. Screening is required within 28 days prior to the start of the study and follow up is required at least 2 weeks after the last dose of study drug.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Dec 2017

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

First Submitted

Initial submission to the registry

November 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

December 4, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 1, 2020

Completed
Last Updated

May 1, 2020

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

November 3, 2017

Results QC Date

April 20, 2020

Last Update Submit

April 30, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (PK): Insulin Lispro Area Under Plasma Concentration Curve Zero to 10 Hours (AUC[0-10])

    Insulin Lispro AUC From Time Zero to 10 hours post dose (AUC\[0-10h\])

    Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn, 45 mn, 50mn, 55 mn, 60mn, 70mn,90mn,120mn,150mn,180mn, 240mn,300mn,360mn,320mn, 480mn, 540mn, and 600mn (10 hours)

Secondary Outcomes (1)

  • Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm

    Predose, every minute from run-in and for the duration of the EC until up to 10 hours postdose

Study Arms (2)

LY900014-U200

EXPERIMENTAL

Single subcutaneous (SC) dose of 15 units (U) LY900014 U-200 in two of four study periods

Drug: LY900014-U200

LY900014-U100

EXPERIMENTAL

Single SC dose of 15 U LY900014 U-100 in two of four study periods

Drug: LY900014-U100

Interventions

LY900014-U200DRUG

Administered SC

Also known as: Ultra-Rapid Lispro
LY900014-U200
LY900014-U100DRUG

Administered SC

Also known as: Ultra-Rapid Lispro
LY900014-U100

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
  • Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)
  • Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
  • Have veins suitable for easy blood collection and glucose solution infusion

You may not qualify if:

  • Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
  • Have previously participated or withdrawn from this study
  • Had blood loss of more than 450 milliliters (mL) within the last 3 months
  • Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)
  • Smoke more than 10 cigarettes per day
  • Are infected with hepatitis B or human immunodeficiency virus (HIV)
  • Are taking illegal drugs

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, Singapore

Location

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
Clinicaltrials.gov@lilly.com
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
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 7, 2017

Study Start

December 4, 2017

Primary Completion

March 15, 2018

Study Completion

March 15, 2018

Last Updated

May 1, 2020

Results First Posted

May 1, 2020

Record last verified: 2018-03

Locations

SG(1)