A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants

NCT ID: NCT01688635

Last Updated: 2014-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-02-28

Brief Summary

The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each period, a single injection will be administered before undergoing a euglycemic clamp that lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects will be documented. Study participation is expected to last up to 14 weeks.

Conditions

Healthy

Study Design

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

Study Groups

LY2963016

Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously, twice during the study

Group Type: EXPERIMENTAL

LY2963016

Intervention Type: DRUG

Administered subcutaneously

US-approved Lantus

Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study

Group Type: EXPERIMENTAL

US Approved Lantus

Intervention Type: DRUG

Administered subcutaneously

Interventions

LY2963016

Administered subcutaneously

Intervention Type: DRUG

US Approved Lantus

Administered subcutaneously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Are overtly healthy males or females
• Have body mass index between 18.5 and 29.9 kilograms per meter square (kg/m^2)
• Are nonsmokers and have not smoked for at least 2 months prior to entering the study
• Have normal blood pressure and pulse rates at screening
• Have electrocardiograms (ECGs) at screening considered as within normal limits
• Have clinical laboratory test results within normal reference ranges

Exclusion Criteria

• Are currently enrolled in or discontinued within the last 30 days from a clinical study involving an investigational drug or device or are concurrently enrolled in any other type of medical research
• 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
• Show evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases
• Show evidence of current use of known drugs of abuse or a history of use within the past year
• Have a history of first-degree relatives known to have diabetes mellitus
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
• Have positive hepatitis B surface antigen at screening
• Intend to use over-the-counter or prescription medication within 7 or 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement medication, or birth control methods)
• Have donated or had a blood loss of 450 milliliters (mL) within 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 24 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-ABEO

Identifier Type: OTHER

Identifier Source: secondary_id

14973

Identifier Type: -

Identifier Source: org_study_id