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Diabetes Mellitus, Type 2Phase 1NCT02588950

A Study of U-500 Insulin (LY041001) in Participants With Type 2 Diabetes

A Phase 1 study testing U-500R in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this two-part study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. In Part A, each participant will receive two treatments, a single dose and a single dose with continuous infusion of U-500R insulin, both administered just under the… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
U-500R
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
12 Jan 2016to 25 May 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 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females with type 2 diabetes mellitus (T2DM)
  • Are current users of U-100, U-200 and/or U-300 insulin/analog as, basal, premixed and/or basal/bolus delivered with any injection device (pens and/or syringe/vial but excluding continuous subcutaneous infusion (CSII)/insulin pump use in the preceding 3 months), taking a total daily dose (TDD) of greater than or equal to (≥) 150 units (U) or at least one dose greater than (>) 100 U as part of a multiple daily injection (MDI) regimen and TDD less than or equal to (≤)3.0 units per kilogram (U/kg)
  • Concomitant antihyperglycemic agent(s) (AHA) therapy may include: metformin (MET), dipeptidyl peptidase 4 inhibitors, pioglitazone (doses ≤30 milligrams per day (mg/day)), glucagon like peptide (GLP)-1 receptor agonists, sodium-glucose co-transporter-2 (SGLT2) inhibitors, except in combination with GLP-1 receptor agonists
  • Participant's antihyperglycemic agent (AHA) therapy must have been stable for ≥3 months (except for weekly GLP-1 receptor agonists which must have been stable for ≥4 months)
  • Have hemoglobin A1c (HbA1c) 7.5-11.5 percent (%)

Who cannot join

  • Have type 1 diabetes mellitus (T1DM), or other types of diabetes mellitus apart from T2DM
  • Have known hypersensitivities or allergies to insulin, excipients contained in insulin products, or related compounds
  • Have used U-500R within 3 months prior to screening
  • Have used rosiglitazone, pramlintide, once weekly or twice daily exenatide, or other injectable or oral antihyperglycemic agent(s) not listed in the inclusion criterion; or are taking oral antidiabetic medications at doses exceeding the respective product labels
  • Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia which may affect reliability of HbA1c measurements

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Profil Institute for Clinical Research

    Chula Vista, California, 91911

Other trials in United States

About this study

Official title: Comparative Pharmacokinetics and Pharmacodynamics of Human Regular U-500 Insulin Administered Subcutaneously as a Bolus Via Syringe Versus Continuous Subcutaneous Insulin Infusion and Characterization of TID and BID Dosing at Steady State in High-Dose Insulin-Treated Subjects With Type 2 Diabetes Mellitus

The purpose of this two-part study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. In Part A, each participant will receive two treatments, a single dose and a single dose with continuous infusion of U-500R insulin, both administered just under the skin. Participants who complete Part A will continue into Part B where they will be assigned to 1 of 2 treatments with U-500R insulin, injected either twice or three times daily under the skin for 5-10 days. This study can last from 7-14 weeks including initial screening and follow up.

Being tested
U-500R
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.

  • U-500RDrug

    Also called Humulin R U-500, LY041001, Humulin

Study groups in NCT02588950
Study groupRoleWhat they receive
Part A: U-500R Single InjectionExperimentalBolus of U-500R administered via single subcutaneous (SC) injection.
Receives: Drug: U-500R
Part A: U-500R CSIIExperimentalBolus of U-500R administered via continuous subcutaneous insulin infusion (CSII).
Receives: Drug: U-500R
Part B: U-500R TIDExperimentalU-500R administered thrice-daily (TID) via SC injection under steady state conditions for 5 to 10 days
Receives: Drug: U-500R
Part B: U-500R BIDExperimentalU-500R administered twice-daily (BID) via SC injection under steady state conditions for 5 to 10 days
Receives: Drug: U-500R

What is being measured

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

  1. Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R

    Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R.

    Measured: Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24 hours (h) post dose

  2. Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to 24 Hours Postdose (AUC[0-24]) of U-500R

    Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve from Zero to 24 Hours Postdose (AUC[0-24]) of U-500R.

    Measured: Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

  3. Part B: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R

    Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R.

    Measured: Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

  4. Part B: Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R

    Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R.

    Measured: Period 3 day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18h post dose

Secondary outcomes (5)

  1. Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R

    Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R.

    Measured: Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose

  2. Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R

    Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R.

    Measured: Period 1 and 2: 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose

  3. Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R

    Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R.

    Measured: Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

  4. Part B: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R

    Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R.

    Measured: Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

  5. Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R

    Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R.

    Measured: Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h 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 posted28 Oct 2015 (estimated)
  2. Study start12 Jan 2016
  3. Primary completion25 May 2017
  4. Study completion25 May 2017

Why it stopped: Slow enrollment

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
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02588950
Sponsor's protocol ID
16021
Other IDs
B5K-EW-IBHG
Status last verified
Oct 2023
First submitted
27 Oct 2015
Last updated
23 Oct 2023
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing U-500R in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in United States.

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 5 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: stopped early, as of the sponsor's last update on 23 Oct 2023. 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 United States. 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 Oct 2023). 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?

Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R (time frame: Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24 hours (h) post dose). The study lists 4 primary outcomes in all. 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 NCT02588950.

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 23 Oct 2023.

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