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| ID | Type | Description | Link |
|---|---|---|---|
| I8H-MC-BDCA | Other Identifier | Eli Lilly and Company | |
| 2016-001048-20 | EudraCT Number |
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This trial is conducted to evaluate the safety of a study drug given by injection under the skin to healthy participants and 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 and tolerability will be documented. This study is approximately 30 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3209590 | Experimental | LY3209590 administered subcutaneously (SC). |
|
| Placebo | Placebo Comparator | Placebo (sterile saline) administered SC. |
|
| Insulin Glargine (Lantus) | Active Comparator | Insulin Glargine administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3209590 | Drug | Administered SC |
| |
| Placebo |
| 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 | Baseline through Day 31 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) of LY3209590 | Baseline through Day 31 | |
| Pharmacodynamics: Average Glucose from 8-Point Glucose Profiles in Participants with T2DM treated with Placebo or LY3209590 | Day 3 |
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Inclusion Criteria:
For all study participants:
For participants with Type 2 Diabetes Mellitus (T2DM):
Exclusion Criteria:
For all study participants:
For participants with T2DM:
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. | Neuss | 41460 | Germany |
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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 |
|
| Insulin Glargine | Drug | Administered SC |
|
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |