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| ID | Type | Description | Link |
|---|---|---|---|
| I2R-MC-BIDP | Other Identifier | Eli Lilly and Company |
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LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, and to measure the quantity of LY2605541 in fat tissue. The study has two parts. It involves intravenous (IV) infusion of the investigational drug and a procedure to measure concentrations in the fat tissue. Both parts of the study will be conducted in participants with type 1 diabetes mellitus (T1DM). Part A and B of the study might take up to 7 weeks to complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Peglispro (LY2605541) | Experimental | Part A Cohort 1: (low dose) priming dose (PD) of 2.00 units (U), 0.92 U/hour (U/h) constant infusion of insulin peglispro Part A Cohort 1: (high dose) PD of 8.00 U, 4.50 U/h constant IV infusion of insulin peglispro Part A Cohort 2: (intermediate dose 1) PD of 4.00 U, 1.84/h constant IV infusion of insulin peglispro Part A Cohort 2: (intermediate dose 2) PD of 6.0 U, 2.76 U/h constant IV infusion of insulin peglispro Part B Insulin Peglispro: PD of 6.00 U, 2.76 constant IV infusion of insulin peglispro and a constant infusion of 6 pico moles per kilogram per minute (pmol/kg/min). IV infusion of sinistrin (250 mg/mL, SOC to achieve a steady state for up to 16 hours). |
|
| Human Insulin | Active Comparator | Constant IV infusion ( 6 pico moles per kilogram perminute [pmol/kg/min]) of human insulin for up to 36 hours. IV infusion of sinistrin (250 mg/mL, SOC to achieve a steady state for up to 16 hours). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Peglispro | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF) | 16, 20, 24, and 28 hours postdose | |
| Part B: Pharmacokinetics: ISF-to-Serum Concentrations | Absolute concentration of ISF of insulin peglispro and human insulin. | 16, 20, 24, and 28 hours postdose |
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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. | Graz | 8036 |
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Cohort 1 Insulin Peglispro Low/High | Participants received a priming dose of 2.00 U and 0.92 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours as treatment 1 and received a priming dose of 8.00 U and 4.50/h constant infusion with at least 6 days between doses) as treatment 2. |
| FG001 | Part A: Cohort 1 Insulin Peglispro High/Low | Participants received a priming dose of 8.00 U and 4.50 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours as treatment 1, and an IV priming dose of 2.00 U and 0.92 U/hour constant infusion as treatment 2. |
| FG002 | Part A: Cohort 2 Insulin Peglispro Intermediate Dose 1 and 2 | Participants received a priming dose of 4.00 U and 1.84 U/h a constant intravenous (IV) of insulin peglispro for 36 hours as treatment 1, and a 6.00 U priming dose and constant infusion of 2.76U/h of insulin peglispro as treatment 2. |
| FG003 | Part A: Cohort 2 Insulin Peglispro, Intermediate Dose 2 and 1 | Participants received a priming dose of 6.00 U and 2.76 U/h constant infusion of insulin peglispro as treatment 1, and 4.00 U and 1.84 U/h constant infusion of insulin peglispro for 36 hours as treatment 2. |
| FG004 | Part B: Insulin Peglispro/Human Insulin | Participant received a priming dose of 6.00 U and 2.76 constant intravenous infusion of insulin peglispro for 36 hours as treatment 1 and 6 pmol/kg/min constant infusion of human insulin as treatment 2. |
| FG005 | Part B: Human Insulin/Insulin Peglispro | Participant received 6 pmol/kg/min constant infusion of human insulin IV as treatment 1 and a priming dose of 6.00 U and 2.76 U/h constant infusion of insulin peglispro and a constant infusion for 36 hours as treatment 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A |
| ||||||||||||||||
| Part B |
|
All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A Low/High Insulin Peglispro | Participants received 4.00 U priming dose and 1.84 U/h constant IV infusion or 8.00 U priming dose and 4.50 U/h constant IV infusionconstant IV infusion of insulin peglispro for 36 hours with up to 2 weeks between doses. |
| BG001 | Part A Intermediate Insulin Peglispro |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF) | All participants who received at least 1 dose of study drug in Part B and had evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomol per liter (pmol/L) | 16, 20, 24, and 28 hours postdose |
|
Up to 11 months
All participants received one dose of study drug except one participant did not receive a dose of human insulin.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Insulin Peglispro 2U | Participants received a priming dose of 2.00 U and 0.92 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000621851 | basal insulin peglispro |
| C587357 | LY2605541 |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Human Insulin | Drug | Administered IV |
|
| Austria |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants received 4.00 U priming dose and 1.84 U/h constant IV infusion or 6.00 U priming dose and 2.76U/h constant IV infusion constant IV infusion of insulin peglispro for 36 hours with up to 2 weeks between doses. |
| BG002 | Part B | Participants first received a priming dose of 8.00 U followed by 2.76 U/h constant intravenous (IV) infusion of LY2605541 for 36 hours or 6 pmol/kg/min constant infusion of human insulin with up to 2 weeks between doses. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| BMI | Mean | Standard Deviation | kilograms per meter squared (kg/m²) |
|
| Body Weight | Mean | Standard Deviation | kilograms (kg) |
|
| HbA1c | Mean | Standard Deviation | percentage of Glycated hemoglobin |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Part B: Pharmacokinetics: ISF-to-Serum Concentrations | Absolute concentration of ISF of insulin peglispro and human insulin. | All participants who received at least 1 dose of study drug in Part B and had evaluable pharmacokinetic data. | Posted | Number | picomol per liter (pmol/L) | 16, 20, 24, and 28 hours postdose |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Part A: Insulin Peglispro 4U | Participants received a priming dose of 4.00 U and 4.50 U/ hour constant intravenous (IV) infusion of insulin peglispro for 36 hours. | 0 | 8 | 3 | 8 |
| EG002 | Part A: Insulin Peglispro 6U | Participant received a priming dose of 6.00 U and 1.84 constant IV infusion of insulin peglispro respectively, for 36 hours. | 0 | 8 | 1 | 8 |
| EG003 | Part A: Insulin Peglispro 8U | Participant received a priming dose of 8.00 U and 2.76 constant IV infusion of insulin peglispro respectively, for 36 hours. | 0 | 4 | 0 | 4 |
| EG004 | Part B: Insulin Peglispro | Participant received a priming dose of 6.00 U and 2.76 constant intravenous infusion of insulin peglispro for 36 hours. | 0 | 12 | 4 | 12 |
| EG005 | Part B: Human Insulin | Participants received 6 pmol/kg/min constant IV infusion of human insulin for up to 36 hours. | 0 | 11 | 2 | 11 |
| Drug hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |