A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine

Criteria

Inclusion Criteria:

• Are overtly healthy males or females

• Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)

• Are nonsmokers

• Have normal blood pressure and pulse rate

• Have an electrocardiogram (ECG) considered as within normal limits

• Have clinical laboratory test results within normal reference range

Exclusion Criteria:

• Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device

• Have known allergies to insulin or its excipients

• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders

• Show evidence of significant active neuropsychiatric disease

• Have a history of first-degree relatives known to have diabetes mellitus

• Have a fasting venous blood glucose >6.0 millimoles per liter (mmol/L)

• Intend to use over-the-counter or prescription medication

• Have donated or had a blood loss of 450 milliliters (mL) or more in the past 3 months

• Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)