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| ID | Type | Description | Link |
|---|---|---|---|
| I9R-MC-BSDA | Other Identifier | Eli Lilly and Company |
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The aim of this trial is to evaluate the safety and tolerability of the study drug known as LY3374849, when given as an injection to healthy participants.
The study will also investigate how quickly the body absorbs and gets rid of LY3374849 and how it affects the levels of blood sugar in comparison to insulin degludec, after a single dose is given by injection under the skin and directly into a vein.
Participation in this study includes screening, which is required within 28 days before start of study and a follow up at least 28 days after receiving the last dose of study drug.
This study has 3 parts:
Parts B and C added per protocol amendment, approved in April 2019.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3374849 - SC (Part A) | Experimental | Single subcutaneous (SC) dose of LY3374849 |
|
| Insulin Degludec - SC (Part A) | Experimental | Single SC dose of insulin degludec |
|
| LY3374849 - SC (Part B) | Experimental | Single dose of LY3374849 administered SC in up to three of three study periods |
|
| LY3374849 - IV (Part B) | Experimental | Single dose of LY3374849 administered intravenously (IV) in up to one of three study periods |
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| LY3374849 - IV (Part C) | Experimental | Single IV dose of LY3374849 in one of two study periods |
|
| Insulin Degludec - IV (Part C) | Experimental | Single IV dose of insulin degludec in one of two study periods |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3374849 - SC | Drug | Administered SC |
| |
| 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 up to study completion (estimated at 11 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Glucodynamics: Total Amount of Glucose Infused (Gtot) | Glucodynamics: Gtot | Baseline up to 36 hours post-dose for each study arm |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3374849 |
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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 |
|---|---|---|---|---|---|---|
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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Parts B and C are crossover design.
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Double-blind in Part A. Open label in Parts B and C.
|
| Insulin Degludec - SC |
| Drug |
Administered SC |
|
| LY3374849 - IV | Drug | Administered IV |
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| Insulin Degludec - IV | Drug | Administered IV |
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Pharmacokinetics: AUC of LY3374849
| Baseline at predose through 6 days post-dose for each study arm |