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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: LY2963016 (Drug); US Approved Lantus (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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.

Clinical Details

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

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

Primary outcome:

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus

Secondary outcome:

Maximum Glucose Infusion Rate (Rmax)

Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure

Eligibility

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

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)

Locations and Contacts

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 117597, Singapore
Additional Information

Starting date: September 2012
Last updated: October 3, 2014

Page last updated: August 23, 2015

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