search
Back to results

Insulin Glulisine in Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

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 Type 2 Diabetes Mellitus

Eligibility Criteria

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

Inclusion criteria : Type 2 diabetes mellitus Body mass index (BMI) between 35 and 40 kg/m2 HbA1c ≤10% Plasma C-peptide levels ≥0.1 nmol/L. Female subjects have to either be postmenopausal, surgically sterilized, or not pregnant and using approved methods of contraception. Exclusion criteria : Type 1 diabetes mellitus, as defined by the World Health Organization Subjects currently taking any insulin History of hypoglycaemic unawareness Injection site skin thickness < or = 8 mm Contra-indications from The medical history and physical examination Laboratory tests (haematology, clinical chemistry, and urinalysis by dipstick) Blood pressure and pulse

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Maximum plasma glucose concentration (GLUmax, mmol/L)
    Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L)
    Time to GLUmax (Tmax, min)

    Secondary Outcome Measures

    Area under the insulin concentration-time curve after injection(μIU.min/mL)
    Maximum concentration (Cmax, μIU/mL)
    Adverse events collection
    Time to maximum concentration (Tmax, min)

    Full Information

    First Posted
    March 2, 2006
    Last Updated
    January 10, 2011
    Sponsor
    Sanofi
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00310297
    Brief Title
    Insulin Glulisine in Type 2 Diabetes Mellitus
    Official Title
    A Randomized, Open Label, Two-arm, Cross-over Design Study to Compare the Pharmacodynamics and Pharmacokinetics of Insulin Glulisine and Insulin Lispro in Obese Patients With Type 2 Diabetes.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    December 2004 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sanofi

    4. Oversight

    5. Study Description

    Brief Summary
    Primary objective: To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes. Secondary objectives: To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes, injected subcutaneously before three standard meals during a 12-hour day. The safety of insulin glulisine, the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid, triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Insulin Glulisine
    Primary Outcome Measure Information:
    Title
    Maximum plasma glucose concentration (GLUmax, mmol/L)
    Time Frame
    During the Study Conduct
    Title
    Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L)
    Time Frame
    during the study conduct
    Title
    Time to GLUmax (Tmax, min)
    Time Frame
    during the study conduct
    Secondary Outcome Measure Information:
    Title
    Area under the insulin concentration-time curve after injection(μIU.min/mL)
    Time Frame
    between 0 h and 1 h (AUC0-1h), 0 h and 1.5 h (AUC0-1.5h), 0 h and 2 h (AUC0-2h) and 0 h and 4 h (AUC0-4h)
    Title
    Maximum concentration (Cmax, μIU/mL)
    Time Frame
    During the study conduct
    Title
    Adverse events collection
    Time Frame
    from the inform consnet signed up to the end of the study
    Title
    Time to maximum concentration (Tmax, min)
    Time Frame
    During the study conduct

    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 2 diabetes mellitus Body mass index (BMI) between 35 and 40 kg/m2 HbA1c ≤10% Plasma C-peptide levels ≥0.1 nmol/L. Female subjects have to either be postmenopausal, surgically sterilized, or not pregnant and using approved methods of contraception. Exclusion criteria : Type 1 diabetes mellitus, as defined by the World Health Organization Subjects currently taking any insulin History of hypoglycaemic unawareness Injection site skin thickness < or = 8 mm Contra-indications from The medical history and physical examination Laboratory tests (haematology, clinical chemistry, and urinalysis by dipstick) Blood pressure and pulse
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Valérie Pilorget, MD
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Insulin Glulisine in Type 2 Diabetes Mellitus

    We'll reach out to this number within 24 hrs