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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-EW-IOQM | Other Identifier | Eli Lilly and Company |
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The study involves 4 injections of insulin lispro and its purpose is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Lispro A | Active Comparator | Insulin Lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200)administered subcutaneously (SC) once in two of four study periods.(Two doses of test [T]). |
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| Insulin Lispro B | Experimental | Insulin Lispro B 20 units (U) of strength 100 U/mL (U-100) administered SC once in two of four study periods.(Two doses of reference [R]). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Lispro | Biological | LY275585 administered SC. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast) | Day 1, predose through 8 hours post dose in each period. | |
| Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax) | Day 1, predose through 8 hours post dose in each period | |
| Pharmacokinetic Parameter: Area Under the Curve(AUC) | Zero to infinity [AUC(0-∞)] |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax) | Day 1, predose through 8 hours post dose in each period. | |
| Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot) | The total amount of glucose infused during the euglycemic clamp procedure. |
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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 | Title | Description |
|---|---|---|
| FG000 | Insulin Lispro Dosing Sequence TRTR | Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test [T] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR. |
| FG001 | Insulin Lispro Dosing Sequence RTRT | Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test [T] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences RTRT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| Interval Between Dosing (7-8 Days) |
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| Second Intervention (1 Day) |
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| Interval Between Dosing (7-8 Days) |
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| Third Intervention (1 Day) |
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| Interval Between Dosing (7-8 Days) |
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| Fourth Intervention (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Lispro Dosing Sequence TRTR | Each subject was administered insulin lispro A U-200 (test [T] on 2 occasions) and insulin lispro B U-100(reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR. |
| BG001 | Insulin Lispro Dosing Sequence RTRT |
| Units | Counts |
|---|---|
| Participants |
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| 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 Zero to Time of Return to Baseline (AUC0-tlast) | 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) | Day 1, predose through 8 hours post dose in each period. |
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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 U-200 subcutaneously (SC) once in two of four study periods. (Two doses of test [T]). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site erythema | General disorders | MedDRA 16.1 | 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 |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Day1, predose through 8 hours post dose in each period. |
| Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax) | The maximum observed glucose infusion rate during the euglycemic clamp procedure. | Day 1, predose through 8 hours post dose in each period. |
| Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax) | Day 1, predose through 8 hours post dose in each period. |
| Singapore |
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Each subject was administered insulin lispro A U-200 (test [T] on 2 occasions) and insulin lispro B U-100 (reference [R] on 2 occasions). Subjects were randomly assigned to dosing sequences RTRT. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax) | 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) | Day 1, predose through 8 hours post dose in each period |
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| Secondary | Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax) | All participants who had at least one study treatment and had evaluable PK data. | Posted | Median | Full Range | hours | Day 1, predose through 8 hours post dose in each period. |
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| 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 pharmacodynamic(PD) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | grams (g) | Day1, predose through 8 hours post dose in each period. |
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| 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 PD data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams per minute (mg/min) | Day 1, predose through 8 hours post dose in each period. |
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| Secondary | Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax) | All participants who had at least one study treatment and had evaluable PD data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 1, predose through 8 hours post dose in each period. |
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| Primary | Pharmacokinetic Parameter: Area Under the Curve(AUC) | All participants who had at least one study treatment and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picomole*hour/liter (pmol*h/L) | Zero to infinity [AUC(0-∞)] |
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| 0 |
| 38 |
| 21 |
| 38 |
| EG001 | Insulin Lispro B | Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]). | 0 | 38 | 16 | 38 |
| Catheter site related reaction | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Infusion site bruising | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Infusion site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Infusion site swelling | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |