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| ID | Type | Description | Link |
|---|---|---|---|
| I6O-FW-BHBA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood. The study has two parts. Participants may enroll in only one part. Each part has four treatment periods in a fixed order. The study will last approximately 8 weeks, 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 |
|---|---|---|---|
| LY2605541-Part A | Experimental | 1.42 units per kilogram (U/kg) of LY2605541 given once daily (QD) for 1 day, subcutaneously (SQ) in 1 of 4 treatment periods. |
|
| Insulin Lispro-Part A | Active Comparator | Single dose 0.36 U/kg of insulin lispro given QD for 1 day, SQ in 1 of 4 treatment periods. |
|
| LY2605541/Lispro Mix 1-Part A | Experimental | Single dose 0.54 U/kg of LY2605541 and 0.36 U/kg insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods. |
|
| LY2605541/Lispro Mix 2-Part A | Experimental | Single dose 1.42 U/kg of LY2605541 and 0.36 insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods. |
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| Insulin Lispro-Part B | Active Comparator | 0.18 U/kg insulin lispro given twice daily (BID) for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2605541 | Drug | Administered subcutaneous (SQ) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Time to Reach Peak Concentration (tmax) of LY2605541 and Insulin Lispro | Pre-dose up to 216 hours post-dose | |
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Lispro | Pre-dose up to 216 hours post-dose | |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-∞) of LY2605541 and Insulin Lispro | Pre-dose up to 216 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Glucose Infusion Rate (Rmax) | Predose up to 32 hours post clamp procedure in all treatment periods | |
| Total Glucose Infused Over Clamp Duration (Gtot) | Predose up to 32 hours post clamp procedure in all treatment periods |
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore | 117597 |
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| ID | Term |
|---|---|
| C587357 | LY2605541 |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| LY2605541/Lispro Mix-Part B | Experimental | 0.71 U/kg LY2605541 and 0.18 U/kg insulin lispro mixture given BID for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A. |
|
| LY2605541 QD-Part B | Experimental | 0.54 U/kg of LY2605541 given QD for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A. |
|
| LY2605541 BID-Part B | Experimental | 0.71 U/kg of LY2605541 given BID for 1 day SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A. |
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| Insulin Lispro | Drug | Administered SQ |
|
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| Singapore |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |