NCT03616977

Brief Summary

The study involves a comparison of 2 formulations of LY900014, which 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
69

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2018

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

August 1, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

August 3, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 30, 2020

Completed
Last Updated

April 30, 2020

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

August 1, 2018

Results QC Date

April 20, 2020

Last Update Submit

April 20, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours(h) (AUC [0-10h]) Following Administration of Each Study Arm

    Pharmacokinetics (PK): Insulin Lispro AUC time zero to 10 hours.

    Period 1 through 4 Day 1: Predose, 5 minutes(m),10m,15m, 20m, 25m, 30m, 35m, 40m, 45m, 50m, 55m, 60m, 70m, 90m, 120m,150m,180m, 240m, 300m, 360m, 420m, 480m, 540m, and 600m postdose

Secondary Outcomes (1)

  • Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Study Arm

    Period 1 through 4 Day 1: Predose, every 10 minutes(m) for 30m prior to dosing; During clamp: every 2.5m for 30m; every 5m for 30 to 120m; every 10m for 120 to 480m, and every 20m for 480m to 600m postdose

Study Arms (2)

LY900014 U-200

EXPERIMENTAL

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

Drug: LY900014 U-200

LY900014 U-100

EXPERIMENTAL

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

Drug: LY900014 U-100

Interventions

LY900014 U-200DRUG

Administered SC

Also known as: Ultra-Rapid Lispro
LY900014 U-200
LY900014 U-100DRUG

Administered SC

Also known as: Ultra-Rapid Lispro
LY900014 U-100

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
  • Had donated blood of more than 450 milliliters (mL) or participated in a clinical trial with similar blood loss 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)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Related Publications (1)

  • Linnebjerg H, LaBell ES, Dellva MA, Coutant DE, Leohr J. Bioequivalence of Ultra Rapid Lispro (URLi) U100 and U200 Formulations in Healthy Subjects. Diabetes Ther. 2020 Aug;11(8):1709-1720. doi: 10.1007/s13300-020-00848-4. Epub 2020 Jun 13.

    PMID: 32535742DERIVED

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
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

August 1, 2018

First Posted

August 6, 2018

Study Start

August 3, 2018

Primary Completion

October 19, 2018

Study Completion

October 19, 2018

Last Updated

April 30, 2020

Results First Posted

April 30, 2020

Record last verified: 2018-11

Locations

SG(1)