Clincosm LogoSign in Get a demo

A Study of Lispro Formulations in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02293551
Collaborator
(none)
54
Enrollment
1
Location
6
Arms
9
Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purposes of this study are to determine:

  • Part A

  • How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation.

  • The safety of insulin lispro in different formulations and any side effects that might be associated with it.

  • Part B:

  • How much insulin lispro from different dose ranges is found in the bloodstream using a test insulin lispro formulation (selected from Part A).

  • The safety of insulin lispro in different formulations and any side effects that might be associated with it.

Participants may only enroll in one part. The study is expected to last up to 10 weeks for each part.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Safety, Tolerability, and Pharmacokinetics of Multiple Novel Insulin Lispro Formulations
Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: Lispro (A)

Formulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods.

Drug: Lispro
Administered SC
Other Names:
  • LY275585

    		•
    Experimental: Part A: Lispro (B)

    Formulation B: Single dose of lispro administered SC in one of five periods.

    Drug: Lispro
    Administered SC
    Other Names:
  • LY275585

    		•
    Experimental: Part A: Lispro (C)

    Formulation C: Single dose of lispro administered SC in one of five periods.

    Drug: Lispro
    Administered SC
    Other Names:
  • LY275585

    		•
    Experimental: Part A: Lispro (D)

    Formulation D: Single dose of lispro administered SC in one of five periods.

    Drug: Lispro
    Administered SC
    Other Names:
  • LY275585

    		•
    Experimental: Part A: Lispro (Reference)

    Reference formulation: Single dose of lispro administered SC in one of five periods.

    Drug: Lispro
    Administered SC
    Other Names:
  • LY275585

    		•
    Experimental: Part B: Lispro

    Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.

    Drug: Lispro
    Administered SC
    Other Names:
  • LY275585

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Part A and B: Pharmacokinetics: Area Under The Concentration Curve (AUC) of LY275585 [Predose through day 1 in each period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Overtly healthy males or females (nonchildbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination
    Exclusion Criteria:
    • Have a fasting plasma glucose less than or equal to (≤) 4.0 millimole per liter (mmol/L) at screening

    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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. Singapore Singapore

    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:
    NCT02293551
    Other Study ID Numbers:
    • 15626
    • F3Z-FW-ITCA
    First Posted:
    Nov 18, 2014
    Last Update Posted:
    Sep 9, 2015
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Insulin Lispro

    Study Results

    No Results Posted as of Sep 9, 2015