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A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01871493
Collaborator
(none)
40
Enrollment
1
Location
8
Arms
3
Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood. The study has two parts. Participants may enroll in only one part. Each part has four treatment periods in a fixed order. The study will last approximately 8 weeks, not including screening. Screening is required within 28 days prior to the start of the study.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1 Study to Evaluate the Pharmacokinetics of LY2605541 Injection and Insulin Lispro Injection Administered as Mixture or as Individual Components in Healthy Subjects
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY2605541-Part A

1.42 units per kilogram (U/kg) of LY2605541 given once daily (QD) for 1 day, subcutaneously (SQ) in 1 of 4 treatment periods.

Drug: LY2605541
Administered subcutaneous (SQ)
Active Comparator: Insulin Lispro-Part A

Single dose 0.36 U/kg of insulin lispro given QD for 1 day, SQ in 1 of 4 treatment periods.

Drug: Insulin Lispro
Administered SQ
Other Names:
  • Humalog

    		•
    Experimental: LY2605541/Lispro Mix 1-Part A

    Single dose 0.54 U/kg of LY2605541 and 0.36 U/kg insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.

    Drug: LY2605541
    Administered subcutaneous (SQ)

    Drug: Insulin Lispro
    Administered SQ
    Other Names:
  • Humalog

    		•
    Experimental: LY2605541/Lispro Mix 2-Part A

    Single dose 1.42 U/kg of LY2605541 and 0.36 insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.

    Drug: LY2605541
    Administered subcutaneous (SQ)

    Drug: Insulin Lispro
    Administered SQ
    Other Names:
  • Humalog

    		•
    Active Comparator: Insulin Lispro-Part B

    0.18 U/kg insulin lispro given twice daily (BID) for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.

    Drug: Insulin Lispro
    Administered SQ
    Other Names:
  • Humalog

    		•
    Experimental: LY2605541/Lispro Mix-Part B

    0.71 U/kg LY2605541 and 0.18 U/kg insulin lispro mixture given BID for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.

    Drug: LY2605541
    Administered subcutaneous (SQ)

    Drug: Insulin Lispro
    Administered SQ
    Other Names:
  • Humalog

    		•
    Experimental: LY2605541 QD-Part B

    0.54 U/kg of LY2605541 given QD for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.

    Drug: LY2605541
    Administered subcutaneous (SQ)
    Experimental: LY2605541 BID-Part B

    0.71 U/kg of LY2605541 given BID for 1 day SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.

    Drug: LY2605541
    Administered subcutaneous (SQ)

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Time to Reach Peak Concentration (tmax) of LY2605541 and Insulin Lispro [Pre-dose up to 216 hours post-dose]

    2. Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Lispro [Pre-dose up to 216 hours post-dose]

    3. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-∞) of LY2605541 and Insulin Lispro [Pre-dose up to 216 hours post-dose]

    Secondary Outcome Measures

    1. Maximum Glucose Infusion Rate (Rmax) [Predose up to 32 hours post clamp procedure in all treatment periods]

    2. Total Glucose Infused Over Clamp Duration (Gtot) [Predose up to 32 hours post clamp procedure in all treatment periods]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Are not of child-bearing potential

    • Have a body mass index (BMI) between 18 and 29.9 kilograms per meter squared (kg/m^2), inclusive

    • Are nonsmokers or have not smoked for at least 2 months prior to entering the study

    Exclusion Criteria:

    • Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin

    • Have a history of first-degree relatives known to have diabetes mellitus

    • Have used systemic glucocorticoids within 3 months prior to entry into the study

    • Have donated blood or had a blood loss of 450 milliliter (mL) within 1 month prior to study enrollment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01871493
    Other Study ID Numbers:
    • 14833
    • I6O-FW-BHBA
    First Posted:
    Jun 6, 2013
    Last Update Posted:
    Oct 21, 2014
    Last Verified:
    Oct 1, 2014
    Additional relevant MeSH terms:
    Insulin Lispro

    Study Results

    No Results Posted as of Oct 21, 2014