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Glulisine Pre- and Postmeal

Primary Purpose

Diabetes Mellitus Type 1

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Insulin glulisine
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 1 focused on measuring Insulin glulisine, Diabetes mellitus Type 1, Postprandial Period, Pharmacokinetics, Glucodynamics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 1 diabetes mellitus Exclusion Criteria:

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Outcome measures: Post-prandial glucose and insulin concentrations. Outcome: In T1DM, insulin glulisine provides a better mimic of the physiological postprandial glucose disposal than RHI.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 9, 2006
    Last Updated
    December 3, 2010
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00290043
    Brief Title
    Glulisine Pre- and Postmeal
    Official Title
    Glucodynamic Response to Pre- and Postmeal Subcutaneous Injection of 0.15 IU/kg HMR1964 Insulin and RHI in Type 1 Diabetic Subjects in an Open, Randomized, Four-way Crossover Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2002 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sanofi

    4. Oversight

    5. Study Description

    Brief Summary
    To investigate in type 1 diabetic patients the glucodynamic response to HMR1964 insulin and RHI (HOE31HPR100) injected subcutaneously before and after a standard meal

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus Type 1
    Keywords
    Insulin glulisine, Diabetes mellitus Type 1, Postprandial Period, Pharmacokinetics, Glucodynamics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Insulin glulisine
    Primary Outcome Measure Information:
    Title
    Outcome measures: Post-prandial glucose and insulin concentrations. Outcome: In T1DM, insulin glulisine provides a better mimic of the physiological postprandial glucose disposal than RHI.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Type 1 diabetes mellitus Exclusion Criteria:
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Klaus Rave, Dr.
    Organizational Affiliation
    Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.sanofi-aventis.com
    Description
    Related Info

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    Glulisine Pre- and Postmeal

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