Diabetes Mellitus, Type 2Phase 1NCT03286751

A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants

A Phase 1 study testing LY900014 and Insulin Lispro in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 2 sites in Germany.

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 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
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: 42 participants
Where: 2 sitesGermany
Study dates: 13 Oct 2017to 6 Feb 2018
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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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 to 30 kilogram per square meter (kg/m²)
Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results
Are nonsmokers, have not smoked for at least 6 months prior to entering the study

Who cannot join

Are currently participating in or completed a clinical trial within the last 30 days
Have previously participated or withdrawn from this study
Have donated blood or have blood loss of more than 500 mL within the past 3 months

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

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.
Mainz, 55116
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.
Neuss, 41460

Other trials in Germany

About this study

Official title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 and Humalog Across Different Subcutaneous Doses in Healthy Subjects

This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs are given 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 in comparison with insulin lispro. The study will last about 7 to 12 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Conditions: Diabetes Mellitus, Type 2
Being tested: LY900014, Insulin Lispro
Medical subject headings: Diabetes Mellitus, Type 2

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 LisproDrug
Also called LY275585, Humalog
Administered SC

Study groups in NCT03286751
Study group	Role	What they receive
LY900014	Experimental	Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods. Receives: Drug: LY900014
Insulin Lispro (Humalog)	Active comparator	Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods. Receives: Drug: Insulin Lispro

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 Versus Time Curve (AUC)
Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose [AUC(0-10h)]
Measured: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose

Secondary outcomes (1)

Glucodynamics: Total Amount of Glucose Infused (Gtot)
Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
Measured: Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose

Timeline

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

13 Oct 20176 Feb 2018

First posted18 Sep 2017
Study start13 Oct 2017
Primary completion6 Feb 2018
Study completion6 Feb 2018

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies 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: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03286751
Sponsor's protocol ID: 16898
Other IDs: 2017-001859-32, I8B-MC-ITSH, 2017
Status last verified: Feb 2018
First submitted: 15 Sep 2017
Last updated: 1 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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
Leohr J, Dellva MA, LaBell E, Coutant DE, Klein O, Plum-Moerschel L, Zijlstra E, Linnebjerg H. Pharmacokinetic and Glucodynamic Responses of Ultra Rapid Lispro vs Lispro Across a Clinically Relevant Range of Subcutaneous Doses in Healthy Subjects. Clin Ther. 2020 Sep;42(9):1762-1777.e4. doi: 10.1016/j.clinthera.2020.07.005. Epub 2020 Sep 6.
PubMed 32900535

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?

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 and Humalog Across Different Subcutaneous Doses in Healthy Subjects
ClinicalTrials.gov ID: NCT03286751
Acronym / sponsor ID: 16898
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 13 Oct 2017 (actual)
Primary completion: 6 Feb 2018 (actual)
Study completion: 6 Feb 2018 (actual)
First posted: 18 Sep 2017 (actual)
Results: Posted 1 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: 2

Arm	Type	Receives
LY900014	Experimental	Drug: LY900014Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods.
Insulin Lispro (Humalog)	Active comparator	Drug: Insulin LisproSingle dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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 to 30 kilogram per square meter (kg/m²)
Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results
Are nonsmokers, have not smoked for at least 6 months prior to entering the study

Key exclusion criteria (3 listed)

Are currently participating in or completed a clinical trial within the last 30 days
Have previously participated or withdrawn from this study
Have donated blood or have blood loss of more than 500 mL within the past 3 months

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
Insulin LisproAlso: LY275585, HumalogAdministered SC	Drug	Insulin Lispro (Humalog)

Primary outcome

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)
Time frame: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose
Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose [AUC(0-10h)]

1 secondary outcome

Glucodynamics: Total Amount of Glucose Infused (Gtot)
Time frame: Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose

Results and safety

Results posted to the registry on 1 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: ABFCED	7	7
Sequence 2: BCADFE	7	7
Sequence 3: CDBEAF	7	7
Sequence 4: DECFBA	7	7
Sequence 5: EFDACB	7	7
Sequence 6: FAEBDC	7	7

Primary outcome: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)

Time frame: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: picomole * hour per liter(pmol*/L)

Measure	7 U Humalog n = 40	7 U LY900014 n = 40	15 U Humalog n = 41	15 U LY900014 n = 40	30 U Humalog n = 40	30 U LY900014 n = 41
Value	649 (16)	656 (17)	1400 (19)	1450 (17)	3050 (18)	3180 (20)

7 U Humalog vs 7 U LY900014: Ratio of Geometric LSMeans: 1.01 (95% CI 0.974 to 1.05), p = 0.5495, Mixed Models Analysis
15 U Humalog vs 15 U LY900014: Ratio of Geometric LSMeans: 1.02 (95% CI 0.986 to 1.06), p = 0.2236, Mixed Models Analysis
30 U Humalog vs 30 U LY900014: Ratio of Geometric LSMeans: 1.03 (95% CI 0.997 to 1.07), p = 0.0727, Mixed Models Analysis

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline to study completion (up to 12 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
7 U LY900014	0 of 40 (0%)	7 of 40 (17.5%)	0 of 40
15 U LY900014	0 of 40 (0%)	5 of 40 (12.5%)	0 of 40
30 U LY900014	0 of 41 (0%)	14 of 41 (34.1%)	0 of 41
7 U Humalog	0 of 40 (0%)	8 of 40 (20%)	0 of 40
15 U Humalog	0 of 41 (0%)	6 of 41 (14.6%)	0 of 41
30 U Humalog	0 of 40 (0%)	5 of 40 (12.5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34041713Leohr 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.
Derived from this study: PubMed 32900535Leohr J, Dellva MA, LaBell E, Coutant DE, Klein O, Plum-Moerschel L, Zijlstra E, Linnebjerg H. Pharmacokinetic and Glucodynamic Responses of Ultra Rapid Lispro vs Lispro Across a Clinically Relevant Range of Subcutaneous Doses in Healthy Subjects. Clin Ther. 2020 Sep;42(9):1762-1777.e4. doi: 10.1016/j.clinthera.2020.07.005. Epub 2020 Sep 6.

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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

2 sites 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 Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 2 sites in Germany.

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 1 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 2 sites in Germany. 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 1 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 Versus Time Curve (AUC) (time frame: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose). 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 NCT03286751, which also lists 2 linked publications.

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 1 May 2020.