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| ID | Type | Description | Link |
|---|---|---|---|
| I8H-JE-BDCK | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3209590 | Experimental | LY3209590 administered subcutaneously (SC). |
|
| Insulin Degludec | Active Comparator | Insulin degludec administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3209590 | Drug | Administered SC. |
| |
| Insulin Degludec |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Hospital Tokyo | Shinjuku-ku | Jp-13 | 162-0053 | Japan | ||
| P-one clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39928225 | Derived | Nasu R, Oura T, Ohwaki K, Imori M, Furihata K. Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes. Diabetes Ther. 2025 Mar;16(3):513-526. doi: 10.1007/s13300-025-01695-x. Epub 2025 Feb 10. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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| Drug |
Administered SC. |
|
PD: Change from Baseline in Fasting Plasma Glucose |
| Day 1 through Day 85 |
| HachiĆji |
| Tokyo |
| 192-0071 |
| Japan |
| Yokohama Minoru Clinic | Yokohama | 232-0064 | Japan |
| D004700 | Endocrine System Diseases |