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CompletedNCT02942654Updated Apr 27, 2020Results posted

A Study of LY900014 Formulation in Healthy Participants

A Phase 1 interventional study of LY900014 and Insulin Lispro in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in Singapore. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-27.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study summary

This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last about 6 to 7 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Overtly 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), 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

Exclusion Criteria:

  • 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  • Have previously participated or withdrawn from this study
  • 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
  • Had blood loss of more than 450 milliliters (mL) within the last month
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    LY900014

    Test formulation. 15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.

    Drug: LY900014

  • Active comparator
    Insulin Lispro

    Reference formulation. 15-U dose of Insulin Lispro administered SC in one of two periods.

    Drug: Insulin Lispro

Interventions

  • DrugLY900014

    Administered subcutaneously (SC)

    Also known as: Ultra-Rapid Lispro

  • DrugInsulin Lispro

    Administered SC

06

What researchers measure

Primary outcomes

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

    Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC\[0-8 Hours\]).

    Time frame: Predose (0), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 210, 240, 300, 330, 360, 420, and 480 minutes, post dose

Secondary outcomes

  1. Glucodynamics (GD): Total Amount of Glucose Infused (Gtot)

    Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 or Insulin Lispro by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.

    Time frame: 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes postdose, and then every 10 minutes until 480 minutes postdose

07

Results

Posted Apr 27, 2020

Participant flow

Period 1
Participant flow — Period 1
MilestoneSequence 1Sequence 2
Started1616
Received at least 1 dose of study drug1616
Completed1616
Not completed00
Washout
Participant flow — Washout
MilestoneSequence 1Sequence 2
Started1616
Completed1616
Not completed00
Period 2
Participant flow — Period 2
MilestoneSequence 1Sequence 2
Started1616
Completed1616
Not completed00

Outcome measures

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

Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC\[0-8 Hours\]).

Time frame:
Predose (0), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 210, 240, 300, 330, 360, 420, and 480 minutes, post dose
Reported as:
Geometric mean · Picomoles*hour/Liter (pmol*h/L)
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])
Picomoles*hour/Liter (pmol*h/L)LY900014Insulin Lispro
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])2050 ± 181930 ± 19
SecondaryGlucodynamics (GD): Total Amount of Glucose Infused (Gtot)

Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 or Insulin Lispro by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.

Time frame:
2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes postdose, and then every 10 minutes until 480 minutes postdose
Reported as:
Geometric mean · Milligrams (mg)
Glucodynamics (GD): Total Amount of Glucose Infused (Gtot)
Milligrams (mg)LY900014Insulin Lispro
Glucodynamics (GD): Total Amount of Glucose Infused (Gtot)115000 ± 32125000 ± 34

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LY900014—0/32 (0%)3/32 (9.4%)
Insulin Lispro—0/32 (0%)7/32 (21.9%)
Most frequent other events
Most frequent other events
EventLY900014Insulin Lispro
Catheter site bruiseGeneral disorders0/322/32
Infusion site bruisingGeneral disorders1/322/32
Injection site erythemaGeneral disorders2/320/32
Vessel puncture site painGeneral disorders0/322/32
Vessel puncture site swellingGeneral disorders0/322/32
HeadacheNervous system disorders0/322/32

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(Years)Overall Study
Mean39.0 ± 10.1
Sex: Female, Male
Sex: Female, Male(Participants)Overall Study
Female3
Male29
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Overall Study
Hispanic or Latino0
Not Hispanic or Latino32
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Overall Study
American Indian or Alaska Native0
Asian32
Native Hawaiian or Other Pacific Islander0
Black or African American0
White0
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Overall Study
Singapore32
08

Study locations

1 site
  • 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
09

References and documents

Publications

  • Leohr J, Dellva MA, Carter K, LaBell E, Linnebjerg H. Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs Humalog(R) Consistently Across Study Populations: A Pooled Analysis of Pharmacokinetic and Glucodynamic Data. Clin Pharmacokinet. 2021 Nov;60(11):1423-1434. doi: 10.1007/s40262-021-01030-0. Epub 2021 May 27. PubMed 34041713 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02942654
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 24, 2016
Start date
Nov 2016
Primary completion
Dec 2016
Completion
Dec 2016
Results posted
Apr 27, 2020
Last update
Apr 27, 2020

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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