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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-EW-IOPY | Other Identifier | Eli Lilly and Company |
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This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.
The 2 formulations of insulin lispro will be referred to here as:
Lispro A
Lispro B
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Lispro A | Experimental | 20 units (U) subcutaneously (SC) |
|
| Insulin lispro B | Active Comparator | 20 units (U) subcutaneously (SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin lispro A | Drug | 20 units (U) subcutaneously (SC). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast] | Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration. | 0 up to 8 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax] | The maximum observed insulin lispro concentration following dosing. | 0 to 8 hours post dose |
| Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax) |
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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 |
41 participants were enrolled into the study. 3 participants discontinued due to subject decision prior to receiving treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Lispro Dosing Sequence ABAB | Each participant was administered insulin lispro A formulation (Treatment A, test - 2 occasions) and insulin lispro B formulation (Treatment B, reference - 2 occasions) in the dosing sequence ABAB. There was an interval of approximately 4 to 7 days between doses. |
| FG001 | Insulin Lispro Dosing Sequence BABA | Each participant was administered insulin lispro A formulation (Treatment A, test - 2 occasions) and insulin lispro B formulation (Treatment B, reference - 2 occasions) in the dosing sequence BABA. There was an interval of approximately 4 to 7 days between doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day ) |
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| Interval Between Dosing (4-7 Days) |
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| Second Intervention (1 Day) |
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| Interval Between Dosing (4-7 Days) |
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| Third Intervention (1 Day) |
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| Interval Between Dosing (4-7 Days) |
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| Fourth Intervention (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Lispro Dosing Sequence ABAB | Each participant was administered insulin lispro A formulation (Treatment A, test - 2 occasions) and insulin lispro B formulation (Treatment B, reference - 2 occasions) in the dosing sequence ABAB. |
| BG001 | Insulin Lispro Dosing Sequence BABA |
| 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 | Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast] | Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration. | All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole*hour/liter (pmol*h/L) | 0 up to 8 hours post dose |
|
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38 participants were randomly assigned to treatment, 38 participants received at least 1 dose of study drug, 36 participants completed all 4 periods of the study. One participant only completed 1 insulin lispro B period and then discontinued. This participant did not complete the insulin lispro A periods.
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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 Lispro A | Insulin lispro A formulation (Treatment A, test - 2 occasions) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye discharge | Eye disorders | MedDRA 13.0 | 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 |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin lispro B | Drug | 20 U subcutaneously (SC). |
|
|
The maximum observed glucose infusion rate during the euglycemic clamp procedure.
| 0 to 8 hours post dose |
| Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax) | Time of maximal glucose infusion rate. | 0 to 8 hours post dose |
| Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot) | The total amount of glucose infused during the euglycemic clamp procedure. | 0 to 8 hours post dose |
| Singapore |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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Each participant was administered insulin lispro A formulation (Treatment A, test - 2 occasions) and insulin lispro B formulation (Treatment B, reference - 2 occasions) in the dosing sequence BABA. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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20 units (U) administered subcutaneously (SC)
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|
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| Secondary | Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax] | The maximum observed insulin lispro concentration following dosing. | All participants who had at least one study treatment and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole/liter (pmol/L) | 0 to 8 hours post dose |
|
|
|
|
| Secondary | Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax) | The maximum observed glucose infusion rate during the euglycemic clamp procedure. | All participants who had at least one study treatment and had evaluable pharmacodynamic (PD) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams per minute (mg/min) | 0 to 8 hours post dose |
|
|
|
|
| Secondary | Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax) | Time of maximal glucose infusion rate. | All participants who had at least one study treatment and had evaluable PD data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 0 to 8 hours post dose |
|
|
|
|
| Secondary | Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot) | The total amount of glucose infused during the euglycemic clamp procedure. | All participants who had at least one study treatment and had evaluable PD data. | Posted | Geometric Mean | Geometric Coefficient of Variation | grams (g) | 0 to 8 hours post dose |
|
|
|
|
| 0 |
| 37 |
| 9 |
| 37 |
| EG001 | Insulin Lispro B | Insulin lispro B formulation (Treatment B, reference - 2 occasions) | 0 | 38 | 12 | 38 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Catheter site haematoma | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |