AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 1NCT04276428

A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus

A Phase 1 study testing LY3209590 and Insulin Degludec in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
LY3209590 and Insulin Degludec
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesJapan
Study dates
28 Feb 2020to 28 Nov 2020
Phase
Phase 1
Are there results?
None posted in the registry

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 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have type 2 diabetes mellitus (T2DM) for at least 1 year
  • Have received a stable daily dose of basal insulin at screening
  • Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening
  • Have a body mass index greater than (>)18.5 and ≤40.0 kilograms per square meter (kg/m²) at screening

Who cannot join

  • Have received a total daily dose of insulin >1.2 units per kilogram (U/kg) of body weight at screening
  • Have received insulins except for basal insulins
  • Have received sulfonylurea at more than half of the maximum approved dose level
  • Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction or history of significant atopy
  • Have had more than 1 episode of severe hypoglycemia within 6 months before entry

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • P-one clinic

    Hachiōji, Tokyo, 192-0071

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Jp-13, 162-0053

  • Yokohama Minoru Clinic

    Yokohama, 232-0064

Other trials in Japan

About this study

Official title: A Multiple-Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 in Japanese Patients With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last almost five months for each participant.

Being tested
LY3209590, Insulin Degludec
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.

  • LY3209590Drug

    Administered SC.

  • Insulin DegludecDrug

    Administered SC.

Study groups in NCT04276428
Study groupRoleWhat they receive
LY3209590ExperimentalLY3209590 administered subcutaneously (SC).
Receives: Drug: LY3209590
Insulin DegludecActive comparatorInsulin degludec administered SC.
Receives: Drug: Insulin Degludec

What is being measured

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

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

    Measured: Baseline through Day 85

Secondary outcomes (2)

  1. Pharmacokinetics (PK): Area Under the Drug-Plasma-Concentration-Versus-Time Curve from Time Zero to 168 Hours Postdose (AUC[0-168]) of LY3209590

    PK: AUC(0-168) of LY3209590

    Measured: Predose on Day 1 through Day 85

  2. Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose

    PD: Change from Baseline in Fasting Plasma Glucose

    Measured: Day 1 through Day 85

Timeline

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

  1. First posted19 Feb 2020
  2. Study start28 Feb 2020
  3. Primary completion28 Nov 2020
  4. Study completion28 Nov 2020

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
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04276428
Sponsor's protocol ID
16983
Other IDs
I8H-JE-BDCK
Status last verified
Dec 2020
First submitted
18 Feb 2020
Last updated
3 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nasu R, Oura T, Ohwaki K, Imori M, Furihata K. Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes. Diabetes Ther. 2025 Mar;16(3):513-526. doi: 10.1007/s13300-025-01695-x. Epub 2025 Feb 10.

    PubMed 39928225

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3209590 and Insulin Degludec in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 3 sites in Japan.

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 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Day 85). 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 NCT04276428, which also lists 1 linked publication.

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 3 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in