Healthy VolunteersPhase 1NCT02317575

A Study of LY900014 Formulations in Healthy Participants

A Phase 1 study testing LY900014 and Insulin Lispro in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: LY900014 and Insulin Lispro
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteSingapore
Study dates: Jan 2015to Sep 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2), 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

Who cannot join

Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial 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Have previously participated or withdrawn from this study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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Singapore, 117597

Other trials in Singapore

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Glucodynamics of Multiple Insulin Lispro (LY900014) Formulations

This study evaluated four test formulations of a glucose lowering drug (LY900014) administered by injection under the skin of the abdomen. The study was conducted in healthy people to investigate how the human body handles LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability were documented. The study was to be conducted in two parts (Part A and Part B) to achieve its objectives. Each part of the study was to last for about 11 to 12 weeks, including screening and follow up. Screening was required within 28 days prior to entering into either study Part A or Part B. Part B was not executed because no suitable formulation was identified.

Conditions: Healthy Volunteers
Being tested: LY900014, Insulin Lispro

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY900014Biological
Also called Ultra-Rapid Lispro
Administered SC
Insulin LisproBiological
Also called LY275585
Administered SC

Study groups in NCT02317575
Study group	Role	What they receive
Part A: LY900014 Test A	Experimental	Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods. Receives: Biological: LY900014
Part A:Insulin Lispro	Experimental	Reference formulation. 15 U insulin lispro administered SC in one of five periods. Receives: Biological: Insulin Lispro
Part A: LY900014 Test B	Experimental	Test Formulation B. Single dose LY900014 administered subcutaneously (SC) in one of five periods. Receives: Biological: LY900014
Part A: LY900014 Test C	Experimental	Test Formulation C. Single dose LY900014administered subcutaneously (SC) in one of five periods. Receives: Biological: LY900014
Part A: LY900014 Test D	Experimental	Test Formulation D. Single dose LY900014administered subcutaneously (SC) in one of five periods. Receives: Biological: LY900014
Part B: LY900014	Experimental	Test formulation selected from Part A. Single dose of LY900014 administered SC in one of four periods. Receives: Biological: LY900014

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast)
Measured: 30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose

Secondary outcomes (4)

Part A: Visual Analog Scale (VAS) Score for Injection Site Pain
The Visual Analog Scale (VAS) assessed injection site pain on a scale of 0-100 millimeter (mm) range (0 = no pain and 100 worst imaginable pain).
Measured: Predose, 1, 20, 60 minutes postdose and at the end of the clamp procedure
Part A: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
Measured: Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes postdose
Part B: Total Amount of Glucose Infused (Gtot) Over the Duration of the Clamp - Interparticipant Variability
Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
Measured: Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes, then every 20 minutes from 300 to 480 minutes postdose
Part B: Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) - Interparticipant Variability
Measured: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Sep 2015

First posted16 Dec 2014 (estimated)
Study startJan 2015
Primary completionApr 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02317575
Sponsor's protocol ID: 15645
Other IDs: I8B-FW-ITRA
Status last verified: Sep 2015
First submitted: 11 Dec 2014
Last updated: 13 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics and Glucodynamics of Multiple Insulin Lispro (LY900014) Formulations
ClinicalTrials.gov ID: NCT02317575
Acronym / sponsor ID: 15645
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Apr 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 16 Dec 2014 (estimated)
Results: Posted 13 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Part A: LY900014 Test A	Experimental	Biological: LY900014Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.
Part A:Insulin Lispro	Experimental	Biological: Insulin LisproReference formulation. 15 U insulin lispro administered SC in one of five periods.
Part A: LY900014 Test B	Experimental	Biological: LY900014Test Formulation B. Single dose LY900014 administered subcutaneously (SC) in one of five periods.
Part A: LY900014 Test C	Experimental	Biological: LY900014Test Formulation C. Single dose LY900014administered subcutaneously (SC) in one of five periods.
Part A: LY900014 Test D	Experimental	Biological: LY900014Test Formulation D. Single dose LY900014administered subcutaneously (SC) in one of five periods.
Part B: LY900014	Experimental	Biological: LY900014Test formulation selected from Part A. Single dose of LY900014 administered SC in one of four periods.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2), 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

Key exclusion criteria (3 listed)

Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial 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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY900014Also: Ultra-Rapid LisproAdministered SC	Biological	Part A: LY900014 Test A, Part A: LY900014 Test B, Part A: LY900014 Test C, Part A: LY900014 Test D, Part B: LY900014
Insulin LisproAlso: LY275585Administered SC	Biological	Part A:Insulin Lispro

Primary outcome

Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast)
Time frame: 30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose

4 secondary outcomes

Part A: Visual Analog Scale (VAS) Score for Injection Site Pain
Time frame: Predose, 1, 20, 60 minutes postdose and at the end of the clamp procedure
Part A: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
Time frame: Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes postdose
Part B: Total Amount of Glucose Infused (Gtot) Over the Duration of the Clamp - Interparticipant Variability
Time frame: Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 300 minutes, then every 20 minutes from 300 to 480 minutes postdose
Part B: Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) - Interparticipant Variability
Time frame: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose

Results and safety

Results posted to the registry on 13 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A Sequence 1, CDABR	5	4
Part A Sequence 2, ABDRC	6	5
Part A Sequence 3, BCRAD	6	6
Part A Sequence 4, DRBCA	6	6
Part A Sequence 5, RACDB	6	6

Primary outcome: Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast)

Time frame: 30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose. Geometric least squares mean (Geometric Coefficient of Variation). Unit: picomol times hour per liter (pmol*h/L)

Measure	Part A: Formulation A, LY900014 n = 27	Part A: Formulation B, LY900014 n = 27	Part A: Formulation C, LY900014 n = 28	Part A: Formulation D, LY900014 n = 27	Part A: Reference n = 27
Value	1720 (20)	1740 (17)	1810 (21)	1750 (19)	1690 (19)

Population analysed: All participants who received at least 1 dose of study drug and completed the dose sequence.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Formulation A, LY900014	0 of 27 (0%)	5 of 27 (18.5%)	Not reported
Part A: Formulation B, LY900014	0 of 27 (0%)	5 of 27 (18.5%)	Not reported
Part A: Forumulation C, LY900014	0 of 28 (0%)	2 of 28 (7.1%)	Not reported
Part A: Forumulation D, LY900014	0 of 27 (0%)	6 of 27 (22.2%)	Not reported
Part A: Reference	0 of 27 (0%)	2 of 27 (7.4%)	Not reported

Limitations and caveats (from the sponsor): Part B was not executed per protocol because no formulation was identified in Part A.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY900014 and Insulin Lispro in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Pharmacokinetics (PK ): Area Under the Concentration Curve From Zero to the Last Recorded Time Post Dose (AUC0-tlast) (time frame: 30 minutes predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02317575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.