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A Study of LY2963016 in 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 Volunteers

Intervention: LY2963016 (Drug); 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


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.

Clinical Details

Official title: Pharmacokinetics and Pharmacodynamics of LY2963016 Compared to Lantus® in Healthy Subjects Following Two Single Subcutaneous Doses

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

Primary outcome:

Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]

Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)

Secondary outcome:

Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus

Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus

Maximum Glucose Infusion Rate (Rmax)

Total Amount of Glucose Infused (Gtot)


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


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


- 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


- 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)

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: July 2012
Last updated: October 3, 2014

Page last updated: August 23, 2015

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