HealthyPhase 1NCT02525744

A Study of a New LY900014 Formulation in Healthy Participants

A Phase 1 study testing LY900014 and Insulin Lispro (Humalog) in people with Healthy, 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
What is being tested?: LY900014 and Insulin Lispro (Humalog)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteSingapore
Study dates: Aug 2015to Oct 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 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Have previously participated or withdrawn from this study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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Singapore

Other trials in Singapore

About this study

Official title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel LY900014 Formulation

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 for about 8 to 9 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Conditions: Healthy
Being tested: LY900014, Insulin Lispro (Humalog)

What participants receive

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

LY900014Drug
Also called Ultra-Rapid Lispro
Administered SC
Insulin Lispro (Humalog)Drug
Also called LY275585, Humalog
Administered SC

Study groups in NCT02525744
Study group	Role	What they receive
LY900014 7.5 Units (U)	Experimental	Single dose of 7.5 U LY900014 administered subcutaneously (SC) in one to two of five periods. Receives: Drug: LY900014
Insulin Lispro	Active comparator	Reference formulation. Single dose of Insulin Lispro administered SC in one to two of five periods. Receives: Drug: Insulin Lispro (Humalog)
LY900014 15 U	Experimental	Single dose of 15 U LY900014 administered subcutaneously (SC) in one to two of five periods. Receives: Drug: LY900014
LY900014 30 U	Experimental	Single dose of 30 U LY900014 administered subcutaneously (SC) in one to two of five periods. Receives: Drug: LY900014

What is being measured

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

Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) )
Measured: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period.

Secondary outcomes (1)

Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
Measured: Every 10 minutes for 30 minutes Predose, Postdose: every 2.5 minutes for 30 minutes, then every 5 minutes until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes

Timeline

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

Aug 2015Oct 2015

First posted17 Aug 2015 (estimated)
Study startAug 2015
Primary completionOct 2015
Study completionOct 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 HealthyStudies 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: Single blind
Who is masked: Participant
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02525744
Sponsor's protocol ID: 15989
Other IDs: I8B-FW-ITRE
Status last verified: Oct 2015
First submitted: 14 Aug 2015
Last updated: 19 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel LY900014 Formulation
ClinicalTrials.gov ID: NCT02525744
Acronym / sponsor ID: 15989
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 17 Aug 2015 (estimated)
Results: Posted 19 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: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
LY900014 7.5 Units (U)	Experimental	Drug: LY900014Single dose of 7.5 U LY900014 administered subcutaneously (SC) in one to two of five periods.
Insulin Lispro	Active comparator	Drug: Insulin Lispro (Humalog)Reference formulation. Single dose of Insulin Lispro administered SC in one to two of five periods.
LY900014 15 U	Experimental	Drug: LY900014Single dose of 15 U LY900014 administered subcutaneously (SC) in one to two of five periods.
LY900014 30 U	Experimental	Drug: LY900014Single dose of 30 U LY900014 administered subcutaneously (SC) in one to two of five 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 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	Drug	LY900014 15 U, LY900014 30 U, LY900014 7.5 Units (U)
Insulin Lispro (Humalog)Also: LY275585, HumalogAdministered SC	Drug	Insulin Lispro

Primary outcome

Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) )
Time frame: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period.

1 secondary outcome

Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
Time frame: Every 10 minutes for 30 minutes Predose, Postdose: every 2.5 minutes for 30 minutes, then every 5 minutes until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes

Results and safety

Results posted to the registry on 19 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
Sequence 1 CBARC	6	6
Sequence 2 ACRBA	6	6
Sequence 3 BRCAB	6	5
Sequence 4 RABCR	6	6

Primary outcome: Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) )

Time frame: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period.. Geometric mean (Geometric Coefficient of Variation). Unit: picomol per hour per L (pmol.h/L)

Measure	LY900014 7.5 U n = 24	LY900014 15 U n = 24	LY900014 30 U n = 24	Insulin Lispro 15 U n = 24
Value	901 (17)	1890 (19)	3970 (15)	1790 (14)

Population analysed: Participants who received at least 1 dose of study drug and had evaluable PK profile data.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
15 U Insulin Lispro (Reference,Humalog)	0 of 23 (0%)	3 of 23 (13%)	0 of 23
LY900014 7.5 U	0 of 22 (0%)	3 of 22 (13.6%)	0 of 22
LY900014 15 U	0 of 22 (0%)	6 of 22 (27.3%)	0 of 22
LY900014 30 U	0 of 23 (0%)	2 of 23 (8.7%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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 (Humalog) in people with Healthy, 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 19 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 19 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?

Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) ) (time frame: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period.). 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 NCT02525744.

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 19 May 2020.