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| ID | Type | Description | Link |
|---|---|---|---|
| I2R-MC-BIDN | Other Identifier | Eli Lilly and Company |
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This study has two parts. Each participant will receive a daily injection of insulin peglispro during one treatment period and a daily injection of insulin glargine during the other treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures to look at how the body uses or stores fats while taking each study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Peglispro | Experimental | Stable dose of insulin peglispro (0.2 - 0.8 units per kilogram [U/kg]) administered subcutaneously (SC) once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen. |
|
| Insulin Glargine | Active Comparator | Stable dose of insulin glargine (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Peglispro | Biological | Daily doses administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations | VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine. | Day 22: 240 minutes (min) to 420 min |
| VLDL-TG Secretion Rate | VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. | Day 22: 240 min to 420 min |
| VLDL-TG Oxidation Rate | VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. | Day 22: 240 min to 420 min |
| VLDL-TG Clearance Rate | VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. | Day 22: 240 min to 420 min |
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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. | Aarhus | 8000 |
Insulin treatments were transitioned by gradual tapering/titration as required at the start of each period and the end of Period 2 based on the participants individual randomization and pre-study therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Peglispro (LY2605541) Then Insulin Glargine | Participants took a stable dose of insulin peglispro (0.2 - 0.8 Units per kilogram [U/kg]) in Period 1 and then insulin glargine (0.2 - 0.8 U/kg) in Period 2 administered subcutaneously (SC). |
| FG001 | Insulin Glargine Then Insulin Peglispro | Participants took a stable dose of insulin glargine (0.2 - 0.8 U/kg) in Period 1 and then insulin peglispro (0.2 - 0.8 U/kg) in Period 2 administered subcutaneously (SC). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants were randomized to receive daily stable doses of either insulin peglispro or insulin glargine (0.2 -0.8 U/kg) administered SC for at least 21 days, in one of two treatment periods. |
| 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 | Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations | VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine. | All participants who were randomized and received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | micromole per Liter (μmol/L) | Day 22: 240 minutes (min) to 420 min |
|
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All randomized participants who received at least one dose of study drug.
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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 | Insulin Peglispro | Participants took a stable dose of Insulin Peglispro (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA 16 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16 | 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 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin Glargine | Biological | Daily doses administered SC. |
|
| Denmark |
| NOT COMPLETED |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants took a stable dose of Insulin glargine (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods.
|
|
| Primary | VLDL-TG Secretion Rate | VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. | All participants who were randomized and took at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | μmol/min | Day 22: 240 min to 420 min |
|
|
|
| Primary | VLDL-TG Oxidation Rate | VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. | All participants who were randomized and received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | μmol/min | Day 22: 240 min to 420 min |
|
|
|
| Primary | VLDL-TG Clearance Rate | VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine. | All participants who were randomized and received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliters per minute (mL/min) | Day 22: 240 min to 420 min |
|
|
|
| 0 |
| 14 |
| 4 |
| 14 |
| EG001 | Insulin Glargine | Participants took a stable dose of Insulin glargine (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods. | 1 | 14 | 5 | 14 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 16 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 16 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 16 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16 | Systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 16 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 16 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16 | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 16 | 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 |