A Study of LY3209590 in Participants With Type 2 Diabetes

Study Overview
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Brief Summary
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This study will evaluate the safety and tolerability of LY3209590 when given by injection under the skin to participants with type 2 diabetes. It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels. Information about any side effects will be documented. This study will last approximately 17 weeks, not including screening. Screening is required within 4 weeks prior to the start of the study.

Official Title
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 Following Multiple Weekly Doses in 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: Participants with Type 2 Diabetes Mellitus (T2DM) for at least 1 year Have a glycated hemoglobin (HbA1c) greater than or equal to (≥) 7.0 percent (%) to less than or equal to (≤) 10.5% at screening Have had no episodes of severe hypoglycemia in the past 6 months Are on stable basal insulin (neutral protamine Hagedorn insulin suspension [NPH] insulin, insulin glargine [U100 or U300], or insulin detemir) with or without metformin, dipeptidyl peptidase IV (DPP-IV) inhibitors, sulfonylureas, and sodium-glucose co-transporter 2 (SGLT-2) inhibitors, at a stable dose for at least 3 months before screening Exclusion Criteria: Have significant lipohypertrophy in the target abdominal injection Have a history of renal impairment Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children) Have proliferative retinopathy or maculopathy and/or severe neuropathy Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening Require daily insulin treatment less than (<) 0.15 unit/kilogram (U/kg) per body weight Are treated with a continuous subcutaneous insulin infusion (CSII) pump Currently receiving degludec insulin therapy, or have been treated with degludec within the past 90 days

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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Accepts Healthy Volunteers

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>Escalating doses of LY3209590 administered by subcutaneous (SC) injection | Drug: LY3209590<br>* Administered SC<br>|
| Active Comparator: Insulin glargine<br>Insulin glargine administered by SC injection | 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 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 17 weeks | 

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 (AUC[0-168]) of LY3209590 | PK: AUC(0-168) of LY3209590 | Week 6 | 
| Pharmacodynamics (PD): Average Glucose from 7-Point Glucose Profiles | PD: Average Glucose from 7-Point Glucose Profiles | Baseline, Day 4, Day 40, Day 43 |