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OpenTrials
Completed

NCT Number: NCT01688635

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

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.

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Key information

Conditions

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LY2963016

Drug

Administered subcutaneously

US Approved Lantus

Drug

Administered subcutaneously

Primary outcomes

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

    Time frame: 30 minutes predose up to 24 hours postdose in all treatment periods

    The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.

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

    Time frame: 30 minutes predose up to 24 hours postdose in all treatment periods

Secondary outcomes

  1. Maximum Glucose Infusion Rate (Rmax)

    Time frame: 30 minutes predose up to 24 hours postdose in all treatment periods

    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.

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

    Time frame: 30 minutes predose up to 24 hours postdose in all treatment periods

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 20, 2012
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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