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A Study of Insulin Peglispro in Healthy Male Japanese 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: NCT01995526
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The main purpose of this study is to evaluate how the body processes the study drug known as insulin peglispro and how the study drug affects blood sugar in healthy male Japanese participants. This study will also evaluate safety of the study drug. The study will last up to 46 days for each participant, not including screening.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Insulin Peglispro Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single Dose Study to Evaluate the Pharmacokinetics and Glucodynamics of Insulin Peglispro (LY2605541) in Healthy Male Japanese Subjects
Study Start Date : December 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Insulin Peglispro
Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1.
 Drug: Insulin Peglispro
Other Name: LY2605541


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro [ Time Frame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose ]
  2. Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro [ Time Frame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose ]
    AUC from time zero to infinity (AUC[0-∞]) of insulin peglispro was evaluated.

  3. Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro [ Time Frame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose ]
  4. Glucodynamics: Maximum Glucose Infusion Rate (Rmax) [ Time Frame: Predose up to 36 hours post clamp procedure ]
  5. Glucodynamics: Total Amount of Glucose Infused (Gtot) [ Time Frame: Predose up to 36 hours post clamp procedure. ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants are overtly healthy male Japanese.
  • Participants have Body Mass Index (BMI) between 18.5 and 25.0 kilograms per square meter (kg/m^2), inclusive.

Exclusion Criteria:

  • Participants have known allergies to insulin peglispro or related compounds.
  • Participants have a fasting venous blood glucose >108 milligrams per deciliter (mg/dL) (>6 millimoles per liter [mmol/L]).
Contacts and Locations
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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): NCT01995526


Locations
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Japan
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.
Fukuoka, Japan, 812-0025
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: NCT01995526    
Other Study ID Numbers: 14682
I2R-JE-BIDK ( Other Identifier: Eli Lilly and Company )
First Posted: November 26, 2013    Key Record Dates
Results First Posted: October 19, 2018
Last Update Posted: October 19, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Insulin
Hypoglycemic Agents
Physiological Effects of Drugs