Type 1 Diabetes MellitusPhase 1NCT03465878

A Study of LY900014 in Participants With Type 1 Diabetes Mellitus

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

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

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus. There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study… Read more about this study

Who is it for?: Ages 6 to 64 years
Conditions the study is for: Type 1 Diabetes Mellitus
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: 56 participants
Where: 2 sitesin 2 countries
Study dates: 26 Mar 2018to 14 Nov 2019
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 6 to 64 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)

Who cannot join

Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
More than one episode of severe hypoglycaemia in the last 6 months
Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
Have obvious clinical signs or symptoms of liver disease
Have a history of renal impairment

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Canada1 site

LMC Endocrinology Centres Ltd.
Toronto, Ontario, M4G 3E8

Other trials in Canada

Germany1 site

Kinderkrankenhaus auf der Bult
Hanover, Lower Saxony, 30173

Other trials in Germany

About this study

Official title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults With Type 1 Diabetes Mellitus

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus.

There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.

Conditions: Type 1 Diabetes Mellitus
Being tested: LY900014, Insulin Lispro
Medical subject headings: Diabetes Mellitus, Type 1

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 via SC injection
Insulin LisproDrug
Also called Humalog, LY275585
Administered via SC injection

Study groups in NCT03465878
Study group	Role	What they receive
LY900014-Part A	Experimental	Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014. Receives: Drug: LY900014
Humalog (Insulin Lispro)-Part A	Active comparator	Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL of Humalog. Receives: Drug: Insulin Lispro
LY900014-Part B	Experimental	Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the continuous subcutaneous insulin infusion (CSII) pump. Receives: Drug: LY900014
Humalog (Insulin Lispro)-Part B	Active comparator	Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump. 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 Curve (AUC) Following Each Treatment Arm for Each Study Part
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.
Measured: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose

Secondary outcomes (1)

Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG∆AUC(0-5h)) Following Each Treatment Arm for Each Study Part.
Measured: -30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 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.

26 Mar 201814 Nov 2019

First posted14 Mar 2018
Study start26 Mar 2018
Primary completion14 Nov 2019
Study completion14 Nov 2019

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 Type 1 Diabetes MellitusStudies 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: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03465878
Sponsor's protocol ID: 16695
Other IDs: I8B-MC-ITSA, 2017-003220-78, 2017
Status last verified: Dec 2019
First submitted: 9 Mar 2018
Last updated: 18 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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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All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 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 Compared to Humalog in Children, Adolescents, and Adults With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT03465878
Acronym / sponsor ID: 16695
Conditions: Type 1 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 26 Mar 2018 (actual)
Primary completion: 14 Nov 2019 (actual)
Study completion: 14 Nov 2019 (actual)
First posted: 14 Mar 2018 (actual)
Results: Posted 18 Jun 2020

Clinical summary

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

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
LY900014-Part A	Experimental	Drug: LY900014Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
Humalog (Insulin Lispro)-Part A	Active comparator	Drug: Insulin LisproParticipants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL of Humalog.
LY900014-Part B	Experimental	Drug: LY900014Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the continuous subcutaneous insulin infusion (CSII) pump.
Humalog (Insulin Lispro)-Part B	Active comparator	Drug: Insulin LisproParticipants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Who may qualify

Ages: 6 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)

Key exclusion criteria (5 listed)

Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
More than one episode of severe hypoglycaemia in the last 6 months
Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
Have obvious clinical signs or symptoms of liver disease
Have a history of renal impairment

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 via SC injection	Drug	LY900014-Part A, LY900014-Part B
Insulin LisproAlso: Humalog, LY275585Administered via SC injection	Drug	Humalog (Insulin Lispro)-Part A, Humalog (Insulin Lispro)-Part B

Primary outcome

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part
Time frame: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.

1 secondary outcome

Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part
Time frame: -30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240 and 300 minutes postdose

Results and safety

Results posted to the registry on 18 Jun 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-Part A	21	21
Sequence 2-Part A	21	20
Sequence 1-Part B	0	0
Sequence 2-Part B	0	0

Primary outcome: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part

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

Measure	Children-LY900014-Part A n = 13	Children-Humalog-Part A n = 13	Adolescents-LY900014-Part A n = 14	Adolescents-Humalog-Part A n = 14	Adults-LY900014-Part A n = 14	Adults-Humalog-Part A n = 14	Children-LY900014-Part B n = 11	Children-Humalog-Part B n = 11	Adolescents-LY900014-Part B n = 13	Adolescents-Humalog-Part B n = 13	Adults-LY900014-Part B n = 12	Adults-Humalog-Part B n = 12
Value	755 (15)	754 (17)	962 (17)	908 (21)	987 (20)	975 (21)	743 (17)	714 (17)	842 (20)	866 (16)	1100 (35)	1070 (35)

Children-LY900014-Part A vs Children-Humalog-Part A: Ratio of geometric least squares means: 0.999 (95% CI 0.918 to 1.09), p = 0.9813, Mixed Models Analysis
Adolescents-LY900014-Part A vs Adolescents-Humalog-Part A: Ratio of geometric least squares means: 1.06 (95% CI 0.976 to 1.15), p = 0.1638, Mixed Models Analysis
Adults-LY900014-Part A vs Adults-Humalog-Part A: Ratio of geometric least squares means: 1.01 (95% CI 0.933 to 1.10), p = 0.7623, Mixed Models Analysis

Population analysed: All randomized 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: From Baseline to Study Completion (Up to 20 Months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Children-LY900014-Part A	0 of 13 (0%)	4 of 13 (30.8%)	0 of 13
Children-Humalog-Part A	0 of 13 (0%)	4 of 13 (30.8%)	0 of 13
Adolescents-LY900014-Part A	1 of 14 (7.1%)	6 of 14 (42.9%)	0 of 14
Adolescents-Humalog-Part A	0 of 14 (0%)	3 of 14 (21.4%)	0 of 14
Adults-LY900014-Part A	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
Adults-Humalog-Part A	0 of 15 (0%)	2 of 15 (13.3%)	0 of 15
Children-LY900014-Part B	0 of 12 (0%)	6 of 12 (50%)	0 of 12
Children-Humalog-Part B	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Adolescents-LY900014-Part B	0 of 13 (0%)	3 of 13 (23.1%)	0 of 13
Adolescents-Humalog-Part B	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Adults-LY900014-Part B	0 of 12 (0%)	3 of 12 (25%)	0 of 12
Adults-Humalog-Part B	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Study of LY900014 in Participants With Type 1 Diabetes MellitusLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Type 1 Diabetes Mellitus

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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 2 countries: 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 Type 1 Diabetes Mellitus, run by Eli Lilly and Company at 2 sites in 2 countries.

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 2 inclusion and 5 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 18 Jun 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 Canada, 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 18 Jun 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 (AUC) Following Each Treatment Arm for Each Study Part (time frame: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 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 NCT03465878.

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 18 Jun 2020.