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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688635
• Other study ID #: 14973
• Secondary ID: I4L-MC-ABEO
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2012
• Last updated: October 3, 2014
• Start date: September 2012
• Est. completion date: February 2013

Study information

• Verified date: October 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSingapore: Domain Specific Review BoardsSingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY2963016
Administered subcutaneously
• US Approved Lantus
Administered subcutaneously

Locations

Country	Name	City	State
Singapore	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus		30 minutes predose up to 24 hours postdose in all treatment periods	No
Secondary	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	No
Secondary	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	No