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Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Insulin LISPRO
Insulin LISPRO
Insulin LISPRO
Sponsored by
Biodel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: ≥18 to ≤70 years
  • Body Mass Index: ≥18 and ≤35 kg/m2
  • Diagnosed with Type 1 Diabetes Mellitus for at least 1 year

Exclusion Criteria:

  • Type 2 diabetes mellitus
  • Serum C-peptide >1.0 ng/mL
  • HbA1c >10.0%
  • History of hypersensitivity to any of the components in the study medication
  • Treatment with any other investigational drug in the last 30 days before dosing.
  • Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    BIOD-238

    BIOD-250

    Humalog

    Arm Description

    Subcutaneous injection

    Subcutaneous injection

    Subcutaneous injection

    Outcomes

    Primary Outcome Measures

    Time to 1/2 maximal insulin concentration

    Secondary Outcome Measures

    Time to maximal insulin concentration
    Time to 1/2 maximal insulin concentration after peak
    Visual analog scale
    AUC 0-30 and AUC 0-60

    Full Information

    First Posted
    March 13, 2013
    Last Updated
    March 14, 2013
    Sponsor
    Biodel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01811849
    Brief Title
    Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes
    Official Title
    A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Safety and Injection Site Toleration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Biodel

    4. Oversight

    5. Study Description

    Brief Summary
    A Double-blind Study of the Pharmacokinetic Properties of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects with Type 1 Diabetes
    Detailed Description
    The purpose of this study is to assess the speed of absorption of BIOD-238 and BIOD-250 compared to Humalog®. Secondary objectives are to assess other pharmacokinetic characteristics of BIOD-238 and BIOD-250 compared to Humalog®, and to evaluate the safety and tolerability of BIOD-238 and BIOD-250 compared to Humalog®.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes
    Keywords
    diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BIOD-238
    Arm Type
    Experimental
    Arm Description
    Subcutaneous injection
    Arm Title
    BIOD-250
    Arm Type
    Experimental
    Arm Description
    Subcutaneous injection
    Arm Title
    Humalog
    Arm Type
    Active Comparator
    Arm Description
    Subcutaneous injection
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin LISPRO
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin LISPRO
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin LISPRO
    Primary Outcome Measure Information:
    Title
    Time to 1/2 maximal insulin concentration
    Time Frame
    480 minutes
    Secondary Outcome Measure Information:
    Title
    Time to maximal insulin concentration
    Time Frame
    480 minutes
    Title
    Time to 1/2 maximal insulin concentration after peak
    Time Frame
    480 minutes
    Title
    Visual analog scale
    Time Frame
    30 minutes
    Title
    AUC 0-30 and AUC 0-60
    Time Frame
    60 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: ≥18 to ≤70 years Body Mass Index: ≥18 and ≤35 kg/m2 Diagnosed with Type 1 Diabetes Mellitus for at least 1 year Exclusion Criteria: Type 2 diabetes mellitus Serum C-peptide >1.0 ng/mL HbA1c >10.0% History of hypersensitivity to any of the components in the study medication Treatment with any other investigational drug in the last 30 days before dosing. Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety, protocol compliance, or interpretation of study results. Caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.

    12. IPD Sharing Statement

    Learn more about this trial

    Pharmacokinetic and Injection Site Toleration of BIOD-238 and BIOD-250 Compared to Humalog® in Subjects With Type 1 Diabetes

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