This study involves 2 single injections of LY2963016 and 2 single injections of Lantus.
There will be at least 6 days between each injection.
The study will compare LY2963016 to Lantus at two different doses.
This study is approximately 10 weeks long, not including screening. Screening is required
within 4 weeks of the start of the study.
Inclusion Criteria:
- Healthy males or females
- Women must be either surgically sterile, post-menopausal, or agree to use a reliable
method of birth control during the study
- Have a body mass index between 18. 5 and 29. 9 kilograms per meter squared (kg/m²)
- Are nonsmokers and have not smoked for at least 6 months prior to entering the study
- Have normal blood pressures and pulse rates at screening, as determined by the
investigator
- Have an electrocardiogram (ECG) at screening considered as within normal limits by
the investigator
- Have clinical laboratory test results within normal reference range for the
population
- Have fasting plasma glucose <110 milligrams per deciliter (mg/dL) (<6. 0 micromoles
per liter [mmol/L]) at screening
- Have venous access sufficient to allow for blood sampling, intravenous drug
administration, and clamp procedures as per the protocol
- Have given written informed consent approved by Lilly and the ethical review board
(ERB) governing the site
Exclusion Criteria:
- Are persons who have previously completed or withdrawn from this study
- Are currently enrolled in or have discontinued within the last 30 days from a
clinical trial involving an investigational drug or device 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 insulin, its excipients, or related drugs or have history of
relevant allergic reactions of any origin
- Have significant history of or current cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematological, or neurological disorders capable of
significantly altering the absorption, metabolism, or elimination of drugs; of
constituting a risk when taking the study medication; or of interfering with the
interpretation of data
- Show evidence of significant active neuropsychiatric disease
- Show evidence of current use of known drugs of abuse or have a history of use within
the past year
- Have a history of first-degree relatives known to have diabetes mellitus
- Show evidence of an acute infection with fever or infectious disease at the time of
study entry
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
HIV antibodies at screening
- Have positive hepatitis B surface antigens at screening
- Intend to use over-the-counter medication within 7 days or prescription medication
within 14 days prior to dosing (apart from vitamin/mineral supplements, occasional
paracetamol, thyroid replacement, or birth control methods)
- Have donated blood or had a blood loss of 450 milliliters (mL) 3 months prior to
study enrollment
- 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 from 48 hours
prior to each dosing until discharged from the clinical research unit (CRU)
