A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01476345
First received: October 5, 2011
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy participants.

Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout period). There are 4 study periods.


Condition Intervention Phase
Diabetes Mellitus
Drug: LY2963016
Drug: Lantus
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Bioequivalence Study Comparing the Pharmacokinetics and Pharmacodynamics of LY2963016 With Insulin Glargine in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus [ Time Frame: 1 hour predose up to 24 hours postdose in all treatment periods ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus [ Time Frame: 1 hour predose up to 24 hours postdose in all treatment periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum Glucose Infusion Rate (Rmax) [ Time Frame: 1 hour predose up to 24 hours postdose in all treatment periods ] [ Designated as safety issue: No ]
    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 Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.

  • Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure [ Time Frame: 1 hour predose up to 24 hours postdose in all treatment periods ] [ Designated as safety issue: No ]
    Gtot is the total glucose infusion over the clamp duration 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 Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.


Enrollment: 80
Study Start Date: November 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2963016
A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days.
Drug: LY2963016
Administered subcutaneously
Experimental: Lantus
A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days.
Drug: Lantus
Administered subcutaneously

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • are overtly healthy males or females, as determined by medical history and physical examination

    • male participants: agree to use a reliable method of birth control during the study.
    • female participants of child-bearing potential must test negative for pregnancy at the time of enrollment and agree to either abstain from sexual activity or to use a medically accepted means of contraception when engaging in sexual intercourse throughout the study, or female participants not of child-bearing potential due to surgical sterilization or menopause
  • have a body weight of at least 55 kilograms (kg), and body mass index (BMI) of 18.5 to 32.0 kilograms/square meter (kg/m²)
  • have clinical laboratory test results within normal reference range for the population
  • have venous access sufficient to allow for blood sampling
  • are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
  • have given written informed consent
  • participants should have a normal oral glucose tolerance test

Exclusion Criteria:

  • are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study; 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 heparin, insulin glargine, related compounds or any components of the formulation
  • are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2963016
  • have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • have an abnormal blood pressure as determined by the investigator
  • have a significant history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication
  • show evidence of significant active neuropsychiatric disease
  • regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • show evidence of hepatitis C and/or positive hepatitis C antibody
  • show evidence of hepatitis B and/or positive hepatitis B surface antigen
  • are women with a positive pregnancy test or women who are lactating
  • intend to use over-the-counter or prescription medication
  • have donated blood of more than 500 milliliters (mL) within the last 56 days before dosing of Period 1
  • 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 for 24 hours before dosing and throughout the duration of each study period
  • smoke more than 10 cigarettes (or equivalent other tobacco products) per day
  • have a fasting blood glucose > 5.5 millimoles/Liter (mmol/L) [>99 milligrams/deciliter (mg/dL)]at screening
  • have a positive test for anti-LY2963016 or anti-glargine antibodies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476345

Locations
South Africa
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.
Bloemfontein, South Africa, 9301
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01476345     History of Changes
Other Study ID Numbers: 13711, I4L-MC-ABEA
Study First Received: October 5, 2011
Results First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014