A Study of LY2963016 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Lantus; Drug: LY2963016

Study type: Interventional

Funder types: Industry

Identifiers

NCT01634165

I4L-MC-ABEM (Other Identifier)

14676

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Are persons who have previously completed or withdrawn from this study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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 4 patient groups

0.3 U/kg LY2963016

Experimental group

Description:

Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016

Treatment:

Drug: LY2963016

0.3 U/kg Lantus

Experimental group

Description:

Single 0.3 U/kg subcutaneous dose of Lantus

Treatment:

Drug: Lantus

0.6 U/kg LY2963016

Experimental group

Description:

Single 0.6 U/kg subcutaneous dose of LY2963016

Treatment:

Drug: LY2963016

0.6 U/kg Lantus

Experimental group

Description:

Single 0.6 U/kg subcutaneous dose of Lantus

Treatment:

Drug: Lantus