Bioequivalence of Two Lispro Formulations

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

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.