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| ID | Type | Description | Link |
|---|---|---|---|
| I8H-MC-BDDC | 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3209590 | Experimental | LY3209590 administered subcutaneously (SC). |
|
| Insulin glargine | Active Comparator | Insulin glargine administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3209590 | Drug | Administered SC. |
| |
| Insulin Glargine |
| 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 |
| 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 |
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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 |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42423945 | Derived | Liu H, Fan Y, Wang Y, Yuan Y, Leohr JK, Liu M, Yu Y. Pharmacokinetics, Pharmacodynamics, and Safety of Once-Weekly Insulin Efsitora Alfa in Chinese Patients with Type 2 Diabetes: A Phase 1 Open-Label, Randomized, Active-Controlled Trial. Adv Ther. 2026 Jul 9. doi: 10.1007/s12325-026-03678-1. Online ahead of print. |
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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 |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
Administered SC. |
|
| Baseline through Week 6 |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |