Bioequivalence of Two Lispro Formulations

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Insulin lispro A

Drug: Insulin lispro B

Study type

Interventional

Funder types

Industry

Identifiers

F3Z-EW-IOPY (Other Identifier)

13300

Details and patient eligibility

About

This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.

Full description

The 2 formulations of insulin lispro will be referred to here as:

Lispro A

Lispro B

Enrollment

41 patients

Sex

All

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.