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

Comparative Pharmacokinetics and Pharmacodynamics of LY2963016 and US-Approved Lantus® After Single-Dose Subcutaneous Administration to Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY2963016; Drug: US Approved Lantus

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117597
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY2963016; Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously, twice during the study	Drug: LY2963016; Administered subcutaneously
Experimental: US-approved Lantus; Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study	Drug: US Approved Lantus; Administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus	The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.	30 minutes predose up to 24 hours postdose in all treatment periods
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus		30 minutes predose up to 24 hours postdose in all treatment periods

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Glucose Infusion Rate (Rmax)	Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.	30 minutes predose up to 24 hours postdose in all treatment periods
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure	Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.	30 minutes predose up to 24 hours postdose in all treatment periods

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: September 17, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 20, 2012

Study Record Updates

• Last Update Posted (Estimate): October 7, 2014
• Last Update Submitted That Met QC Criteria: October 3, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Volunteers
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: 14973; I4L-MC-ABEO (Other Identifier: Eli Lilly and Company)