Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY2963016 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01634165
Recruitment Status : Completed
First Posted : July 6, 2012
Results First Posted : October 7, 2014
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: LY2963016 Drug: Lantus Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics and Pharmacodynamics of LY2963016 Compared to Lantus® in Healthy Subjects Following Two Single Subcutaneous Doses
Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.3 U/kg LY2963016
Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016
Drug: LY2963016
Administered subcutaneously

Experimental: 0.3 U/kg Lantus
Single 0.3 U/kg subcutaneous dose of Lantus
Drug: Lantus
Administered subcutaneously

Experimental: 0.6 U/kg LY2963016
Single 0.6 U/kg subcutaneous dose of LY2963016
Drug: LY2963016
Administered subcutaneously

Experimental: 0.6 U/kg Lantus
Single 0.6 U/kg subcutaneous dose of Lantus
Drug: Lantus
Administered subcutaneously




Primary Outcome Measures :
  1. Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)] [ Time Frame: Predose up to 24 hours after administration of study drug ]
    Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.

  2. Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax) [ Time Frame: Predose up to 24 hours after administration of study drug ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus [ Time Frame: Predose up to 24 hours after administration of study drug ]
    Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.

  2. Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus [ Time Frame: Predose up to 24 hours after administration of study drug ]
    Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.

  3. Maximum Glucose Infusion Rate (Rmax) [ Time Frame: Postdose up to 24 hours after administration of study drug ]
    Rmax 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.

  4. Total Amount of Glucose Infused (Gtot) [ Time Frame: Postdose up to 24 hours after administration of study drug ]
    Gtot 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 investigator
  • 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 population
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634165


Locations
Layout table for location information
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, Singapore, 117597
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01634165    
Other Study ID Numbers: 14676
I4L-MC-ABEM ( Other Identifier: Eli Lilly and Company )
First Posted: July 6, 2012    Key Record Dates
Results First Posted: October 7, 2014
Last Update Posted: October 7, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs