Diabetes Mellitus, Type 1Phase 1NCT03341299

A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus

A Phase 1 study testing LY900014 and Insulin Lispro in people with Diabetes Mellitus, Type 1, 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

The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 1
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: 36 participants
Where: 2 sitesGermany
Study dates: 13 Nov 2017to 3 Apr 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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 35.0 kg/m²
Have a glycated hemoglobin (HbA1c) ≤9.0% at screening
Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) for at least 3 months before screening with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram per day (U/kg/day)

Who cannot join

Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening.
Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator.
Are treated with a CSII (insulin pump)

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
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

Other trials in Germany

About this study

Official title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog® in Patients With T1DM

Conditions: Diabetes Mellitus, Type 1
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.

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

Study groups in NCT03341299
Study group	Role	What they receive
LY900014 Before Meal	Experimental	Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods. Receives: Biological: LY900014
LY900014 After Meal	Experimental	Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods. Receives: Biological: LY900014
Insulin Lispro (Humalog) Before Meal	Active comparator	Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods. Receives: Biological: Insulin Lispro
Insulin Lispro (Humalog) After Meal	Active comparator	Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods. Receives: Biological: 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)
PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .
Measured: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 hours)

Secondary outcomes (1)

Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve
GD: Area Under The Baseline Subtracted Glucose Concentration Curve for Each Treatment Arm
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.

13 Nov 20173 Apr 2018

First posted14 Nov 2017
Study start13 Nov 2017
Primary completion3 Apr 2018
Study completion3 Apr 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.
Other trials for Diabetes Mellitus, Type 1Studies 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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03341299
Sponsor's protocol ID: 16641
Other IDs: I8B-MC-ITRV, 2017-001500-30, 2017
Status last verified: Apr 2018
First submitted: 9 Nov 2017
Last updated: 14 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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?

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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 14 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 Compared to Humalog® in Patients With T1DM
ClinicalTrials.gov ID: NCT03341299
Acronym / sponsor ID: 16641
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 13 Nov 2017 (actual)
Primary completion: 3 Apr 2018 (actual)
Study completion: 3 Apr 2018 (actual)
First posted: 14 Nov 2017 (actual)
Results: Posted 14 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: 4

Arm	Type	Receives
LY900014 Before Meal	Experimental	Biological: LY900014Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.
LY900014 After Meal	Experimental	Biological: LY900014Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.
Insulin Lispro (Humalog) Before Meal	Active comparator	Biological: Insulin LisproIndividualized dose of insulin lispro administered SC immediately before meal in one of four study periods.
Insulin Lispro (Humalog) After Meal	Active comparator	Biological: Insulin LisproIndividualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 35.0 kg/m²
Have a glycated hemoglobin (HbA1c) ≤9.0% at screening
Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) for at least 3 months before screening with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram per day (U/kg/day)

Key exclusion criteria (5 listed)

Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening.
Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator.
Are treated with a CSII (insulin pump)

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	LY900014 After Meal, LY900014 Before Meal
Insulin LisproAlso: LY275585, HumalogAdministered SC	Biological	Insulin Lispro (Humalog) After Meal, Insulin Lispro (Humalog) Before Meal

Primary outcome

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC)
Time frame: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 hours)
PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .

1 secondary outcome

Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve
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 14 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
Cohort 1	9	9
Cohort 2	9	9
Cohort 3	9	9
Cohort 4	9	9

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

Time frame: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 hours). Geometric mean (Geometric Coefficient of Variation). Unit: picomoles times hour per Liter

Measure	LY900014 n = 35	Insulin Lispro (Humalog) n = 35
Value	970 (57)	968 (56)

LY900014 vs Insulin Lispro (Humalog): Ratio of geometric least square means: 0.991 (95% CI 0.932 to 1.05), p = 0.7734, Mixed Models Analysis

Population analysed: All randomized participants who received at least 1 dose of study drug. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY900014 Before Meal	0 of 35 (0%)	0 of 35 (0%)	0 of 35
LY900014 After Meal	0 of 35 (0%)	3 of 35 (8.6%)	0 of 35
Insulin Lispro (Humalog) Before Meal	0 of 36 (0%)	3 of 36 (8.3%)	0 of 36
Insulin Lispro (Humalog) After Meal	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 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

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 1, 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 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 14 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 14 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 (AUC) (time frame: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 hours)). 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 NCT03341299.

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 14 May 2020.