Bioequivalence of Two Lispro Formulations

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

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

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.