A Multiple Dose Study of LY3209590 in Participants With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to measure the activity and insulin time action of LY3209590 at steady state in participants with type 2 diabetes mellitus. The total study duration is approximately 182 days.

Official Title
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A Phase 1, Open-Label, Multiple-Dose Study to Investigate Steady-State Pharmacokinetics and Pharmacodynamics During a Euglycemic Clamp of LY3209590 in Participants With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: LY3209590


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with T2DM. Participants who are insulin naive or have not received insulin treatment for at least 6 months prior to screening. Have glycated hemoglobin (HbA1c) of ≥7.0% to ≤9.5%, HbA1c of ≥6.5% to ≤9.5% for participants on treatment with sulfonylureas and/or SGLT2 inhibitors who require washout. Have a body mass index (BMI) between 27 and 40 kg/m2. Male or female participants who are willing to comply with the contraception requirements consistent with local regulations. Be willing to allow blood sample collection, reliable and to be available for the duration of the study as required for the study protocol. Exclusion Criteria: Have known or suspected allergic reactions to study drugs, related compounds, excipients, and devices used in the study. Have a specific type of diabetes other than T2DM. Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c. Participants with a history of kidney complications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3209590<br>LY3209590 administered subcutaneously (SC) | Drug: LY3209590<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area under the concentration curve during one dosing interval at steady state (AUCss) of LY3209590 | PK: AUCss of LY3209590 | One dosing interval at steady-state from 0 to 168 hr after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: Total amount of glucose infused during one dosing interval at steady state (Gtot,SS) of LY3209590 | PK: Gtot,SS of LY3209590 | One dosing interval at steady-state from 0 to 168 hr after last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clamp, Diabetes, Type 2