A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Participants

Lilly

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus

Treatments

Drug: LY2963016

Drug: Lantus

Study type

Interventional

Funder types

Industry

Identifiers

NCT01476345

I4L-MC-ABEA (Other Identifier)

13711

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 participants.

Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout period). There are 4 study periods.

Enrollment

80 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

are overtly healthy males or females, as determined by medical history and physical examination
- male participants: agree to use a reliable method of birth control during the study.
- female participants of child-bearing potential must test negative for pregnancy at the time of enrollment and agree to either abstain from sexual activity or to use a medically accepted means of contraception when engaging in sexual intercourse throughout the study, or female participants not of child-bearing potential due to surgical sterilization or menopause
have a body weight of at least 55 kilograms (kg), and body mass index (BMI) of 18.5 to 32.0 kilograms/square meter (kg/m²)
have clinical laboratory test results within normal reference range for the population
have venous access sufficient to allow for blood sampling
are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
have given written informed consent
participants should have a normal oral glucose tolerance test

Exclusion criteria

are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
have known allergies to heparin, insulin glargine, related compounds or any components of the formulation
are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2963016
have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
have an abnormal blood pressure as determined by the investigator
have a significant history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication
show evidence of significant active neuropsychiatric disease
regularly use known drugs of abuse and/or show positive findings on urinary drug screening
show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
show evidence of hepatitis C and/or positive hepatitis C antibody
show evidence of hepatitis B and/or positive hepatitis B surface antigen
are women with a positive pregnancy test or women who are lactating
intend to use over-the-counter or prescription medication
have donated blood of more than 500 milliliters (mL) within the last 56 days before dosing of Period 1
have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to stop alcohol consumption for 24 hours before dosing and throughout the duration of each study period
smoke more than 10 cigarettes (or equivalent other tobacco products) per day
have a fasting blood glucose > 5.5 millimoles/Liter (mmol/L) [>99 milligrams/deciliter (mg/dL)]at screening
have a positive test for anti-LY2963016 or anti-glargine antibodies