Diabetes Mellitus, Type 2Phase 1NCT03232983

A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants

A Phase 1 study testing LY900014 (SC) and LY900014 (IV) in people with Diabetes Mellitus, Type 2, 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

Search all trials

Trial summary

This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh and arm. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: LY900014 (SC) and LY900014 (IV)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteSingapore
Study dates: 14 Aug 2017to 9 Nov 2017
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 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
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 or any other type of medical research judged to be incompatible with this study
Have previously participated or withdrawn from this study
Had blood loss of more than 450 milliliters (mL) within the last 3 months

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, 117597

Other trials in Singapore

About this study

Official title: Effect of Injection Site on the Relative and Absolute Bioavailability of Single Dose of LY900014 in Healthy Subjects

This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh and arm.

The study will be conducted in healthy people to investigate the effect of different injection sites on the amount of insulin lispro in the bloodstream.

Side effects and tolerability will be documented. The study will last for about 10 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 (SC), LY900014 (IV)
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.

LY900014 (SC)Drug
Also called Ultra-Rapid Lispro
Administered SC
LY900014 (IV)Drug
Also called Ultra-Rapid Lispro
Administered IV

Study groups in NCT03232983
Study group	Role	What they receive
LY900014 (SC Abdomen)	Experimental	Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in one period Receives: Drug: LY900014 (SC)
LY900014 (SC Thigh)	Experimental	Single dose of 15-U of LY900014 administered SC into the thigh in one period Receives: Drug: LY900014 (SC)
LY900014 (SC Arm)	Experimental	Single dose of 15-U of LY900014 administered SC into the arm (deltoid) in one period Receives: Drug: LY900014 (SC)
LY900014 (IV)	Active comparator	Single dose of 15-U of LY900014 administered intravenously (IV) in one period Receives: Drug: LY900014 (IV)

What is being measured

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

Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration
Pharmacokinetics(PK): Insulin lispro AUC from time zero to 10 hours post dose [AUC(0-10h)].
Measured: Day 1: Pre-dose, 2.5, 5, 10, 15, 20, 25, 30, 40, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose

Secondary outcomes (1)

Total Amount of Glucose Infused (Gtot) Over Duration of the Clamp Procedure
Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. During the euglycemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 by adjusting the exogenous glucose infusion rate.
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 120 to 480 minutes and every 10 minutes for 480 to 600 minutes post-dose

Timeline

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

14 Aug 20179 Nov 2017

First posted28 Jul 2017
Study start14 Aug 2017
Primary completion9 Nov 2017
Study completion9 Nov 2017

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 (1)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: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03232983
Sponsor's protocol ID: 16639
Other IDs: I8B-MC-ITRT
Status last verified: Dec 2017
First submitted: 26 Jul 2017
Last updated: 30 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Leohr JK, Dellva MA, LaBell E, Coutant DE, Linnebjerg H. Evaluation of the Pharmacokinetic Profile of Ultra Rapid Lispro Administered Subcutaneously at Different Injection Sites. Clin Ther. 2022 Jun;44(6):836-847. doi: 10.1016/j.clinthera.2022.04.001. Epub 2022 May 13.
PubMed 35577602

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

Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
Recruiting
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
PreDiabetes, Diet, Healthy
Not yet recruiting
Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
Diabetes (Insulin-requiring, Type 1 or Type 2)
Recruiting
6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
Type 2 Diabetes

All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Injection Site on the Relative and Absolute Bioavailability of Single Dose of LY900014 in Healthy Subjects
ClinicalTrials.gov ID: NCT03232983
Acronym / sponsor ID: 16639
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 14 Aug 2017 (actual)
Primary completion: 9 Nov 2017 (actual)
Study completion: 9 Nov 2017 (actual)
First posted: 28 Jul 2017 (actual)
Results: Posted 30 Apr 2020

Clinical summary

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

This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh and arm.

The study will be conducted in healthy people to investigate the effect of different injection sites on the amount of insulin lispro in the bloodstream.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
LY900014 (SC Abdomen)	Experimental	Drug: LY900014 (SC)Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in one period
LY900014 (SC Thigh)	Experimental	Drug: LY900014 (SC)Single dose of 15-U of LY900014 administered SC into the thigh in one period
LY900014 (SC Arm)	Experimental	Drug: LY900014 (SC)Single dose of 15-U of LY900014 administered SC into the arm (deltoid) in one period
LY900014 (IV)	Active comparator	Drug: LY900014 (IV)Single dose of 15-U of LY900014 administered intravenously (IV) in one period

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 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
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 or any other type of medical research judged to be incompatible with this study
Have previously participated or withdrawn from this study
Had blood loss of more than 450 milliliters (mL) within the last 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
LY900014 (SC)Also: Ultra-Rapid LisproAdministered SC	Drug	LY900014 (SC Abdomen), LY900014 (SC Arm), LY900014 (SC Thigh)
LY900014 (IV)Also: Ultra-Rapid LisproAdministered IV	Drug	LY900014 (IV)

Primary outcome

Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration
Time frame: Day 1: Pre-dose, 2.5, 5, 10, 15, 20, 25, 30, 40, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose
Pharmacokinetics(PK): Insulin lispro AUC from time zero to 10 hours post dose [AUC(0-10h)].

1 secondary outcome

Total Amount of Glucose Infused (Gtot) Over Duration of the Clamp Procedure
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 120 to 480 minutes and every 10 minutes for 480 to 600 minutes post-dose

Results and safety

Results posted to the registry on 30 Apr 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
LY900014 Treatment Sequence 1: Abdomen,Thigh, Deltoid(Arm), IV	7	7
LY900014 Treatment Sequence 2: Deltoid, Abdomen, IV, Thigh	7	7
LY900014 Treatment Sequence 3: IV, Deltoid, Thigh, Abdomen	7	6
LY900014 Treatment Sequence 4: Thigh, IV, Abdomen, Deltoid	7	7

Primary outcome: Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration

Time frame: Day 1: Pre-dose, 2.5, 5, 10, 15, 20, 25, 30, 40, 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/Liter (pmol * hr/L)

Measure	LY900014 (SC Abdomen) n = 25	LY900014 (SC Deltoid) n = 26	LY900014 (IV) n = 27	LY900014 (SC Thigh) n = 26
Value	1760 (20)	1800 (16)	2770 (22)	1750 (19)

LY900014 (SC Abdomen) vs LY900014 (SC Deltoid): Ratio of Geometric Least Squares Means: 1.03 (90% CI 0.992 to 1.07), Mixed Models Analysis
LY900014 (SC Abdomen) vs LY900014 (SC Thigh): Ratio of Geometric Least Squares Means: 1.00 (90% CI 0.962 to 1.04), Mixed Models Analysis

Population analysed: All participants who have received at least one dose of study drug and have measurable insulin lispro concentrations and evaluable PK data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline to end of study (up to 49 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
15-U LY900014 Abdomen	0 of 25 (0%)	6 of 25 (24%)	0 of 25
15-U LY900014 Thigh	0 of 26 (0%)	7 of 26 (26.9%)	0 of 26
15-U LY900014 Deltoid	0 of 26 (0%)	11 of 26 (42.3%)	0 of 26
15-U LY900014 IV	0 of 28 (0%)	4 of 28 (14.3%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35577602Leohr JK, Dellva MA, LaBell E, Coutant DE, Linnebjerg H. Evaluation of the Pharmacokinetic Profile of Ultra Rapid Lispro Administered Subcutaneously at Different Injection Sites. Clin Ther. 2022 Jun;44(6):836-847. doi: 10.1016/j.clinthera.2022.04.001. Epub 2022 May 13.

Related trials for Diabetes Mellitus, Type 2

Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
Recruiting
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
PreDiabetes, Diet, Healthy
Not yet recruiting
Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
Diabetes (Insulin-requiring, Type 1 or Type 2)
Recruiting
6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
Type 2 Diabetes

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 (SC) and LY900014 (IV) in people with Diabetes Mellitus, Type 2, 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 30 Apr 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 30 Apr 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: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration (time frame: Day 1: Pre-dose, 2.5, 5, 10, 15, 20, 25, 30, 40, 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 NCT03232983, which also lists 1 linked publication.

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 30 Apr 2020.