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

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ClinicalTrials.gov Identifier: NCT01688635
Recruitment Status : Completed
First Posted : September 20, 2012
Results First Posted : October 7, 2014
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Comparative Pharmacokinetics and Pharmacodynamics of LY2963016 and US-Approved Lantus® After Single-Dose Subcutaneous Administration to Healthy Subjects
Study Start Date : September 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: LY2963016
Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously, twice during the study
 Drug: LY2963016
Administered subcutaneously
Experimental: US-approved Lantus
Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study
 Drug: US Approved Lantus
Administered subcutaneously


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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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): NCT01688635


Locations
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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
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01688635    
Other Study ID Numbers: 14973
I4L-MC-ABEO ( Other Identifier: Eli Lilly and Company )
First Posted: September 20, 2012    Key Record Dates
Results First Posted: October 7, 2014
Last Update Posted: October 7, 2014
Last Verified: October 2014
Keywords provided by Eli Lilly and Company:
Volunteers
Additional relevant MeSH terms:
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Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs