Diabetes Mellitus, Type 2Phase 1NCT05596747
A Study of LY3209590 in Chinese Participants With Type 2 Diabetes Mellitus
A Phase 1 study testing LY3209590 and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in China.
Trial summary
The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Chinese participants with type 2 diabetes mellitus who are on a stable dose of basal insulin. Side effects and tolerability will be documented. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY3209590 and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2022to 10 Oct 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) and treated with basal insulin and up to one non-insulin anti-hyperglycemic medication.
- Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
- 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
- Native Chinese participant who has both parents and all 4 grandparents of Chinese origin.
Who cannot join
- Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes
- Have a history of ketoacidosis or hyperosmolar state/coma episode or severe hypoglycemia or hypoglycemia unawareness in the 6 months prior to screening
- Are receiving insulin other than once daily basal insulin
- Have any active infectious or serious disease or major organs insufficiency
- Women who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
About this study
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Chinese 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 Chinese participants with type 2 diabetes mellitus who are on a stable dose of basal insulin. Side effects and tolerability will be documented. Blood samples will be taken to assess how the body processes the study drug and the effect of the study drug on blood sugar levels. The study will last up to 18 weeks and may include 18 visits for each participant.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY3209590, Insulin Glargine
- 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 GlargineDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3209590 | Experimental | LY3209590 administered subcutaneously (SC). Receives: Drug: LY3209590 |
| Insulin glargine | Active comparator | Insulin glargine administered SC. Receives: Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Number of Participants with One or More AEs and SAEs Considered by the Investigator to be Related to Study Drug Administration
Measured: Baseline up to Week 12
Incidence and Severity of Hypoglycemia
Incidence and Severity of Hypoglycemia
Measured: Baseline up to Week 12
Secondary outcomes (2)
Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
PD: Change from Baseline in Fasting Plasma Glucose
Measured: Baseline through Week 6
PD: Change from Baseline in 7-Point Glucose
PD: Change from Baseline in 7-Point Glucose
Measured: Baseline through Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start30 Nov 2022
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596747
- Sponsor's protocol ID
- 18221
- Other IDs
- I8H-MC-BDDC
- Status last verified
- Dec 2023
- First submitted
- 25 Oct 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu H, Fan Y, Wang Y, Yuan Y, Leohr JK, Liu M, Yu Y. Pharmacokinetics, Pharmacodynamics, and Safety of Once-Weekly Insulin Efsitora Alfa in Chinese Patients with Type 2 Diabetes: A Phase 1 Open-Label, Randomized, Active-Controlled Trial. Adv Ther. 2026 Jul 9. doi: 10.1007/s12325-026-03678-1. Online ahead of print.
PubMed 42423945
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Chinese Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05596747
- Acronym / sponsor ID
- 18221
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Chinese participants with type 2 diabetes mellitus who are on a stable dose of basal insulin. Side effects and tolerability will be documented. Blood samples will be taken to assess how the body processes the study drug and the effect of the study drug on blood sugar levels. The study will last up to 18 weeks and may include 18 visits for each participant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3209590 | Experimental | Drug: LY3209590LY3209590 administered subcutaneously (SC). |
| Insulin glargine | Active comparator | Drug: Insulin GlargineInsulin glargine administered SC. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have been diagnosed with Type 2 Diabetes Mellitus (T2DM) and treated with basal insulin and up to one non-insulin anti-hyperglycemic medication.
- Body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m²)
- 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
- Native Chinese participant who has both parents and all 4 grandparents of Chinese origin.
Key exclusion criteria (5 listed)
- Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes
- Have a history of ketoacidosis or hyperosmolar state/coma episode or severe hypoglycemia or hypoglycemia unawareness in the 6 months prior to screening
- Are receiving insulin other than once daily basal insulin
- Have any active infectious or serious disease or major organs insufficiency
- Women who are pregnant or lactating
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 |
|---|---|---|
| LY3209590Administered SC. | Drug | LY3209590 |
| Insulin GlargineAdministered SC. | Drug | Insulin glargine |
Primary outcome
Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline up to Week 12
Number of Participants with One or More AEs and SAEs Considered by the Investigator to be Related to Study Drug Administration
Incidence and Severity of Hypoglycemia
Time frame: Baseline up to Week 12
Incidence and Severity of Hypoglycemia
2 secondary outcomes
Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
Time frame: Baseline through Week 6
PD: Change from Baseline in 7-Point Glucose
Time frame: Baseline through Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Derived from this study: PubMed 42423945Liu H, Fan Y, Wang Y, Yuan Y, Leohr JK, Liu M, Yu Y. Pharmacokinetics, Pharmacodynamics, and Safety of Once-Weekly Insulin Efsitora Alfa in Chinese Patients with Type 2 Diabetes: A Phase 1 Open-Label, Randomized, Active-Controlled Trial. Adv Ther. 2026 Jul 9. doi: 10.1007/s12325-026-03678-1. Online ahead of print.
- 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 LY3209590 and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in China.
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: finished, as of the sponsor's last update on 2 Jan 2024. 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 China. 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 Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline up to Week 12). The study lists 2 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 NCT05596747, 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 2 Jan 2024.