A Study of LY3209590 in Chinese 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 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.

Official Title
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in Chinese 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 Glargine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 glargine<br>Insulin glargine administered SC. | Drug: Insulin Glargine<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 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 | Baseline up to Week 12 | 
| Incidence and Severity of Hypoglycemia | Incidence and Severity of Hypoglycemia | Baseline up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose | PD: Change from Baseline in Fasting Plasma Glucose | Baseline through Week 6 | 
| PD: Change from Baseline in 7-Point Glucose | PD: Change from Baseline in 7-Point Glucose | Baseline through Week 6 |