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| ID | Type | Description | Link |
|---|---|---|---|
| I2R-MC-BIAV | 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, what effect this investigational drug has on the body, and how much should be given. This study will also measure how much of the investigational drug gets into the blood stream and how long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including screening. Screening will be performed within 30 days of the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Cohort A; LY2605541 | Experimental | Healthy participants received 5.1 milliunits/minute (mU/min) in Period 1, 10.2 mU/min in Period 2, and 15.3 mU/min in Period 3, administered intravenously (IV) over 8 hours. All periods were separated by a minimum 6-day washout period |
|
| Part A, Cohort A; Insulin Glargine | Active Comparator | Healthy participants received insulin glargine (30 milliunits/meter squared/minute [mU/m^2/min]) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period |
|
| Part A, Cohort B; LY2605541 | Experimental | Healthy participants received 15.3 mU/min in Period 1, 37.0 mU/min in Period 2, and 74.1 mU/min in Period 3, administered IV over 8 hours. All periods were separated by a minimum 6-day washout period. |
|
| Part A, Cohort B; Insulin Glargine | Active Comparator | Healthy participants received insulin glargine (60 mU/m^2/min) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period. |
|
| Part B; LY2605541 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2605541 | Drug | LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL). |
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| Measure | Description | Time Frame |
|---|---|---|
| Part B: Glucodynamics: Endogenous Glucose Output | The percent suppression from baseline in endogenous glucose production (EGP) is presented. Percent EGP change from baseline was calculated by (1-[last 2 hours of EGP/basal EGP])*100. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours. | Baseline, up to 10 hours (duration of the euglycemic glucose clamp) |
| Part B: Glycodynamics: Glucose Disposal | The fold change from baseline in glucose disappearance rate (GDR) is presented. The fold GDR increase from baseline was calculated by last 2 hours of GDR/basal GDR. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours. | Baseline, up to 10 hours (duration of the euglycemic glucose clamp) |
| Part B: Glycodynamics: Maximum Rate of Glucose Disposal | The maximum rate of glucose disposal (Rdmax) is presented. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours. | Baseline, up to 10 hours (duration of the euglycemic glucose clamp) |
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Inclusion Criteria:
All Participants
Healthy Participants ONLY
Participants with T1DM ONLY
Exclusion Criteria:
All Participants
Healthy Participants ONLY
• Regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen).
Participants with T1DM ONLY
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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. | San Diego | California |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A, Cohort A: LY2605541 First, Then Insulin Glargine | LY2605541: Healthy participants received 5.1 milliunits/minute (mU/min) in Period 1, 10.2 mU/min in Period 2, and 15.3 mU/min in Period 3, administered intravenously (IV) over 8 hours. Insulin glargine: Healthy participants received 30 milliunits/meter squared/minute [mU/m^2/min]) administered IV over 8 hours in Period 4 |
| FG001 | Part A, Cohort B: LY2605541 First, Then Insulin Glargine | LY2605541: Healthy participants received 15.3 mU/min in Period 1, 37.0 mU/min in Period 2, and 74.1 mU/min in Period 3, administered IV over 8 hours. Insulin glargine: Healthy participants received 20 mU/m^2/min administered IV over 8 hours in Period 4 |
| FG002 | Part B: LY2605541 | LY2605541: Participants with T1DM received 15.3 mU/min in 1 of 4 Periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours. |
| FG003 | Part B: Insulin Glargine | Insulin glargine: Participants with T1DM received 10 mU/m^2/min in 1 of 4 Periods and received 20 mU/m^2/min in 1 of 4 Periods, administered IV over 8 hours. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A, Period 1 |
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| Part A, Washout of at Least 6 Days |
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| Part A, Period 2 |
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| Part A, Washout of at Least 6 Days |
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| Part A, Period 3 |
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| Part A, Washout of at Least 6 Days |
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| Part A, Period 4 |
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| Part B, Period 1 |
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| Part B, Washout of at Least 6 Days |
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| Part B, Period 2 |
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| Part B, Washout of at Least 6 Days |
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| Part B, Period 3 |
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| Part B, Washout of at Least 6 Days |
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| Part B, Period 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A | All participants who received at least 1 dose of study drug in Part A of the study. |
| BG001 | Part B | All participants who received at least 1 dose of study drug in Part B of the study. |
| 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: Glucodynamics: Endogenous Glucose Output | The percent suppression from baseline in endogenous glucose production (EGP) is presented. Percent EGP change from baseline was calculated by (1-[last 2 hours of EGP/basal EGP])*100. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours. | Participants who received at least 1 dose of study drug with evaluable EGP data | Posted | Mean | Standard Deviation | percent of suppression | Baseline, up to 10 hours (duration of the euglycemic glucose clamp) |
|
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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, Cohort A: 5.1 mU/Min LY2605541 | LY2605541: Healthy participants received 5.1 mU/min in Period 1, administered IV over 8 hours |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus bradycardia | Cardiac disorders | MedDRA 15.0 | 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 |
|---|---|
| C587357 | LY2605541 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Participants with T1DM received 15.3 mU/min in 1 of 4 study periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours. Each dose was separated by a minimum 6-day washout period.
|
| Part B; Insulin Glargine | Active Comparator | Participants with T1DM received 1 insulin glargine dose per study period (10 and 20 mU/m^2/min) administered IV over 8 hours in 2 of 4 study periods. Each dose was separated by a minimum 6-day washout period. |
|
| Insulin glargine | Other | Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial. |
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| United States |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| OG001 | 74.1 mU/Min LY2605541 | LY2605541: Participants with T1DM received 74.1 mU/min in 1 of 4 Periods in Part B, administered IV for up to 10 hours |
| OG002 | 10 mU/m^2/Min Insulin Glargine | Insulin glargine: Participants with T1DM received 10 mU/m^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours |
| OG003 | 20 mU/m^2/Min Insulin Glargine | Insulin glargine: Participants with T1DM received 20 mU/m^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours |
|
|
| Primary | Part B: Glycodynamics: Glucose Disposal | The fold change from baseline in glucose disappearance rate (GDR) is presented. The fold GDR increase from baseline was calculated by last 2 hours of GDR/basal GDR. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours. | Participants who received at least 1 dose of study drug with evaluable GDR data. | Posted | Mean | Standard Deviation | fold change | Baseline, up to 10 hours (duration of the euglycemic glucose clamp) |
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| Primary | Part B: Glycodynamics: Maximum Rate of Glucose Disposal | The maximum rate of glucose disposal (Rdmax) is presented. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours. | Participants who received at least 1 dose of study drug with evaluable Rdmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams/minute/kilograms (mg/min/kg) | Baseline, up to 10 hours (duration of the euglycemic glucose clamp) |
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|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Part A, Cohort A: 10.2 mU/Min LY2605541 | LY2605541: Healthy participants received 10.2 mU/min in Period 2, administered IV over 8 hours | 0 | 4 | 2 | 4 |
| EG002 | Part A, Cohort A or Cohort B: 15.3 mU/Min LY2605541 | LY2605541: Healthy participants received 15.3 mU/min in Period 3 of Part A Cohort A and 15.3 mU/min in Period 1 of Part A Cohort B, administered IV over 8 hours | 0 | 8 | 3 | 8 |
| EG003 | Part A, Cohort A: 30 mU/m^2/Min Insulin Glargine | Insulin glargine: Healthy participants received 30 mU/m^2/min administered IV over 8 hours in Period 4 | 0 | 4 | 2 | 4 |
| EG004 | Part A, Cohort B: 37.0 mU/Min LY2605541 | LY2605541: Healthy participants received 37.0 mU/min in Period 2 administered IV over 8 hours | 0 | 4 | 1 | 4 |
| EG005 | Part A, Cohort B: 74.1 mU/Min LY2605541 | LY2605541: Healthy participants received 74.1 mU/min in Period 3, administered IV over 8 hours | 0 | 4 | 0 | 4 |
| EG006 | Part A, Cohort B: 20 mU/m^2/Min Insulin Glargine | Insulin glargine: Healthy participants received 20 mU/m^2/min administered IV over 8 hours in Period 4 | 0 | 4 | 1 | 4 |
| EG007 | Part B: 15.3 mU/Min LY2605541 | LY2605541: Participants with T1DM received 15.3 mU/min in 1 of 4 Periods in Part B, administered IV for up to 10 hours | 0 | 14 | 1 | 14 |
| EG008 | Part B: 74.1 mU/Min LY2605541 | LY2605541: Participants with T1DM received 74.1 mU/min in 1 of 4 Periods in Part B, administered IV for up to 10 hours | 0 | 13 | 3 | 13 |
| EG009 | Part B: 10 mU/m^2/Min Insulin Glargine | Insulin glargine: Participants with T1DM received 10 mU/m^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours | 0 | 13 | 2 | 13 |
| EG010 | Part B: 20 mU/m^2/Min Insulin Glargine | Insulin glargine: Participants with T1DM received 20 mU/m^2/min in 1 of 4 Periods in Part B, administered IV over 8 hours | 0 | 13 | 5 | 13 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Infusion site discomfort | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Vessel puncture site reaction | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Groin abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA 15.0 | 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 |