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| ID | Type | Description | Link |
|---|---|---|---|
| I8H-MC-BDCB | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3209590 | Experimental | Escalating doses of LY3209590 administered by subcutaneous (SC) injection |
|
| Insulin glargine | Active Comparator | Insulin glargine administered by SC injection |
|
| 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 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 |
| 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 |
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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 |
|---|---|---|---|---|---|---|
| Miami Research Associates | South Miami | Florida | 33143 | United States | ||
| High Point Clinical Trials Center |
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| Label | URL |
|---|---|
| A Study of LY3209590 in Participants With Type 2 Diabetes | View source |
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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 |
|
PD: Average Glucose from 7-Point Glucose Profiles
| Baseline, Day 4, Day 40, Day 43 |
| High Point |
| North Carolina |
| 27265 |
| United States |
| LMC Endocrinology Centres Ltd. | Toronto | Ontario | M4G 3E8 | Canada |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |