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Diabetes Mellitus, Type 1Phase 1NCT03166124

A Study of LY900014 in Elderly and Younger Adult 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 compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks. Read more about this study

Who is it for?
Ages 18 years and older
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
80 participants
Where
2 sitesGermany
Study dates
24 May 2017to 18 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 18 years and older
  • 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)
  • Have a body mass index (BMI) of 18.5 to 30.0 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
  • Have a history of renal impairment
  • Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives
  • Have proliferative retinopathy or maculopathy and/or severe neuropathy

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: Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro Following Single Dose Administration in Elderly and Younger Adults With Type 1 Diabetes Mellitus

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

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.

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 SC

  • Insulin LisproDrug

    Also called Humalog, LY275585

    Administered SC

Study groups in NCT03166124
Study groupRoleWhat they receive
Elderly Adults LY900014ExperimentalSingle, subcutaneous (SC) 15-U dose of LY900014 in the elderly adult group.
Receives: Drug: LY900014
Elderly Adults Insulin LisproActive comparatorSingle, SC 15-U dose of insulin lispro (Humalog) in in the elderly adult group.
Receives: Drug: Insulin Lispro
Younger Adults LY900014ExperimentalSingle, SC 15-U dose of LY900014 in the younger adult group.
Receives: Drug: LY900014
Younger Adults Insulin LisproActive comparatorSingle, SC 15-U dose of insulin lispro (Humalog) in the younger adult group.
Receives: Drug: Insulin Lispro

What is being measured

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

  1. Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm

    Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose [AUC(0-10h)] for each treatment arm.

    Measured: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose

Secondary outcomes (1)

  1. Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm

    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.

    Measured: 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.

  1. First posted24 May 2017
  2. Study start24 May 2017
  3. Primary completion18 Nov 2017
  4. Study completion18 Nov 2017

Resources

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
NCT03166124
Sponsor's protocol ID
16637
Other IDs
I8B-MC-ITRR
Status last verified
Dec 2017
First submitted
23 May 2017
Last updated
30 Apr 2020
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

  • Linnebjerg H, Zhang Q, LaBell E, Dellva MA, Coutant DE, Hovelmann U, Plum-Morschel L, Herbrand T, Leohr J. Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog(R) (Lispro) in Younger Adults and Elderly Patients with Type 1 Diabetes Mellitus: A Randomised Controlled Trial. Clin Pharmacokinet. 2020 Dec;59(12):1589-1599. doi: 10.1007/s40262-020-00903-0.

    PubMed 32468447

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 4 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 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 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) for Each Treatment Arm (time frame: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 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 NCT03166124, 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 30 Apr 2020.

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