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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: LY3209590
* Drug: Insulin Degludec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 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
Allocation: Randomized
Intervention Model: Parallel 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>|
| Active Comparator: Insulin Degludec<br>Insulin degludec administered SC. | Drug: Insulin Degludec<br>* Administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline through Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Predose on Day 1 through Day 85 | 
| Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose | PD: Change from Baseline in Fasting Plasma Glucose | Day 1 through Day 85 |