Bioequivalence of Two Lispro Formulations

Study Overview
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Brief Summary
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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.

Detailed Description
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The 2 formulations of insulin lispro will be referred to here as: Lispro A Lispro B

Official Title
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Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Insulin lispro A
* Drug: Insulin lispro B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are healthy males or females. Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m^2) Are nonsmokers. Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening. Exclusion Criteria: History of first-degree relatives known to have diabetes mellitus. Evidence of significant active neuropsychiatric disease. Evidence of an acute infection with fever or infectious disease. Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods). Have used systemic glucocorticoids within 3 months prior to entry into the study. Have donated blood of 1 unit or more within the last 3 months prior to study entry. Excessive alcohol intake Have a fasting venous blood glucose (FBG, plasma) >6 millimoles/liter (mmol/L) at screening. Have positive hepatitis B surface antigen.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Lispro A<br>20 units (U) subcutaneously (SC) | Drug: Insulin lispro A<br>* 20 units (U) subcutaneously (SC).<br>* Other names: LY275585;|
| Active Comparator: Insulin lispro B<br>20 units (U) subcutaneously (SC) | Drug: Insulin lispro B<br>* 20 U subcutaneously (SC).<br>* Other names: LY275585;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin, lispro