Diabetes Mellitus, Type 1Phase 1NCT03449433

A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus

A Phase 1 study testing LY900014, Insulin Lispro and Insulin Aspart in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site 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 70 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: LY900014, Insulin Lispro and Insulin Aspart
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteGermany
Study dates: 15 Mar 2018to 14 Aug 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
Healthy volunteers accepted
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 to 35.0 kilogram per meter square (kg/m²)
Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)
Have had no episodes of severe hypoglycaemia in the last 6 months

Who cannot join

Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data

Trial locations and contacts

1 site in 1 country.

Germany1 site

Profil Institut für Stoffwechselforschung
Neuss, North Rhine-Westphalia, 41460

Other trials in Germany

About this study

Official title: A Mixed Meal Tolerance Test Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LY900014 Compared to Humalog Following a Single Dose in Adults With Type 1 Diabetes

Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin. The study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it. A test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products. The safety and tolerability of LY900014 will also be assessed. Screening is required within 14 days prior to the lead in. For each participant, the study will last up to 91 days.

Conditions: Diabetes Mellitus, Type 1
Being tested: LY900014, Insulin Lispro, Insulin Aspart
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 SC
Insulin LisproDrug
Also called Humalog®, LY275585
Administered SC
Insulin AspartDrug
Also called NovoRapid®
Administered SC
Insulin AspartDrug
Also called Fiasp®
Administered SC

Study groups in NCT03449433
Study group	Role	What they receive
LY900014	Experimental	T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014. Receives: Drug: LY900014
Insulin Lispro (Humalog®)	Active comparator	T1DM participants received a single, individualized, SC dose of insulin lispro. Receives: Drug: Insulin Lispro
Insulin Aspart (NovoRapid®)	Active comparator	T1DM participants received a single, individualized, SC dose of insulin aspart. Receives: Drug: Insulin Aspart
Insulin Aspart (Fiasp®)	Active comparator	T1DM participants received a single, individualized, SC dose of insulin aspart. Receives: Drug: Insulin Aspart
Healthy Participants	No intervention	Healthy participants who received no study drug.

What is being measured

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

Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm
PK: Insulin Lispro or Insulin Aspart AUC(0-7h)
Measured: 0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose

Secondary outcomes (1)

Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
Measured: 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

Timeline

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

15 Mar 201814 Aug 2018

First posted28 Feb 2018
Study start15 Mar 2018
Primary completion14 Aug 2018
Study completion14 Aug 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: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03449433
Sponsor's protocol ID: 16911
Other IDs: I8B-MC-ITSL, 2017-003459-47, 2017
Status last verified: Sep 2018
First submitted: 23 Feb 2018
Last updated: 30 Apr 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?

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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: A Mixed Meal Tolerance Test Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LY900014 Compared to Humalog Following a Single Dose in Adults With Type 1 Diabetes
ClinicalTrials.gov ID: NCT03449433
Acronym / sponsor ID: 16911
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 15 Mar 2018 (actual)
Primary completion: 14 Aug 2018 (actual)
Study completion: 14 Aug 2018 (actual)
First posted: 28 Feb 2018 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
LY900014	Experimental	Drug: LY900014T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014.
Insulin Lispro (Humalog®)	Active comparator	Drug: Insulin LisproT1DM participants received a single, individualized, SC dose of insulin lispro.
Insulin Aspart (NovoRapid®)	Active comparator	Drug: Insulin AspartT1DM participants received a single, individualized, SC dose of insulin aspart.
Insulin Aspart (Fiasp®)	Active comparator	Drug: Insulin AspartT1DM participants received a single, individualized, SC dose of insulin aspart.
Healthy Participants	No intervention	–Healthy participants who received no study drug.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: 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 to 35.0 kilogram per meter square (kg/m²)
Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)
Have had no episodes of severe hypoglycaemia in the last 6 months

Key exclusion criteria (1 listed)

Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data

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: Humalog®, LY275585Administered SC	Drug	Insulin Lispro (Humalog®)
Insulin AspartAlso: NovoRapid®Administered SC	Drug	Insulin Aspart (NovoRapid®)
Insulin AspartAlso: Fiasp®Administered SC	Drug	Insulin Aspart (Fiasp®)

Primary outcome

Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm
Time frame: 0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose
PK: Insulin Lispro or Insulin Aspart AUC(0-7h)

1 secondary outcome

Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
Time frame: 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 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
Type 1 Diabetes Mellitus (T1DM) Cohort 1	17	17
T1DM Cohort 2	16	16
T1DM Cohort 3	18	18
T1DM Cohort 4	17	17
Healthy Participants	12	12

Primary outcome: Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm

Time frame: 0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose. Geometric mean (Geometric Coefficient of Variation). Unit: picomols times hour per Liter

Measure	LY900014 n = 62	Insulin Lispro (Humalog®) n = 62	Insulin Aspart (NovoRapid®) n = 62	Insulin Aspart (Fiasp®) n = 62
Value	786 (36)	756 (37)	938 (41)	928 (36)

LY900014 vs Insulin Lispro (Humalog®): Ratio of LS Means: 1.04 (95% CI 0.985 to 1.10)

Population analysed: All randomized, T1DM participants who received at least 1 dose of study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: up to 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY900014	0 of 68 (0%)	0 of 68 (0%)	0 of 68
Insulin Lispro (Humalog®)	0 of 67 (0%)	0 of 67 (0%)	0 of 67
Insulin Aspart (Fiasp®)	0 of 68 (0%)	0 of 68 (0%)	0 of 68
Insulin Aspart (NovoRapid®)	0 of 67 (0%)	0 of 67 (0%)	0 of 67
Healthy Participants	0 of 12 (0%)	0 of 12 (0%)	0 of 12

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.
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, Insulin Lispro and Insulin Aspart in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site 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 1 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 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 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 (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm (time frame: 0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 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 NCT03449433.

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.