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

Lilly

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus

Treatments

Drug: LY2963016

Drug: Lantus

Study type

Interventional

Funder types

Industry

Identifiers

NCT01374178

I4L-MC-ABEI (Other Identifier)

14094

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

21 to 60 years old

Volunteers

Accepts Healthy Volunteers

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)