A Study of LY2963016 in Healthy Participants

NCT ID: NCT01634165

Last Updated: 2014-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-09-30

Brief Summary

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

0.3 U/kg LY2963016

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

Group Type: EXPERIMENTAL

LY2963016

Intervention Type: DRUG

Administered subcutaneously

0.3 U/kg Lantus

Single 0.3 U/kg subcutaneous dose of Lantus

Group Type: EXPERIMENTAL

Lantus

Intervention Type: DRUG

Administered subcutaneously

0.6 U/kg LY2963016

Single 0.6 U/kg subcutaneous dose of LY2963016

Group Type: EXPERIMENTAL

LY2963016

Intervention Type: DRUG

Administered subcutaneously

0.6 U/kg Lantus

Single 0.6 U/kg subcutaneous dose of Lantus

Group Type: EXPERIMENTAL

Lantus

Intervention Type: DRUG

Administered subcutaneously

Interventions

LY2963016

Administered subcutaneously

Intervention Type: DRUG

Lantus

Administered subcutaneously

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Singapore, , Singapore

Countries

Singapore

Other Identifiers

I4L-MC-ABEM

Identifier Type: OTHER

Identifier Source: secondary_id

14676

Identifier Type: -

Identifier Source: org_study_id