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Status:

COMPLETED

baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

Lead Sponsor:

Sanofi

Conditions:

Diabetes Mellitus, Type 1

Eligibility:

All Genders

18-60 years

Phase:

PHASE4

Brief Summary

Primary Objective: To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Ty...

Detailed Description

After a two-week run-in period patients will enter a six-month treatment period. Estimated study duration per patient : 26 weeks (including a 2-week run-in period).

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Known Type 1 diabetic patients (male or female) treated with any type of insulin regimen, except:
  • continuous subcutaneous insulin infusion (CSII, or pump), and
  • patients already treated with insulin glargine
  • Age: 18-60 years inclusive
  • HbA1c: 8% - 10% assessed over the past 6 month
  • At least 1 year of continuous insulin treatment
  • Willingness to accept, and ability to follow:
  • a basal bolus regimen (glargine x1 and glulisine x3 per day),
  • self-monitoring blood glucose (SMBG)
  • a fixed meal plan, or CHO counting
  • Signed informed consent obtained prior to any study procedure
  • Criteria for entry in the treatment period:
  • HbA1c 8-10% assessed between week -2 and week 0
  • Serum creatinine ≤135 micromol/L in men and ≤110 micromol/L in women
  • Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) lower or equal to three times the upper limit of normal
  • Pregnancy test negative if women of childbearing potential
  • Exclusion criteria:
  • History of hypersensitivity to insulin glargine and/or insulin glulisine
  • Pregnant, breast-feeding or women of childbearing potential not using efficient contraception
  • Brittle diabetes
  • Known impaired renal function defined as serum creatinine \> 135 micromol/L in men and \> 110 micromol/L in women at study entry
  • Known impaired hepatic function defined as Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal at study entry
  • Diabetes ketoacidosis
  • History of drug or alcohol abuse
  • Psychiatric or mental disease
  • Inclusion in another study in the past 6 months or previous inclusion in this study
  • Patient unable or unwilling to manage properly the basal bolus regimen
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Exclusion

    Key Trial Info

    Start Date :

    November 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2013

    Estimated Enrollment :

    206 Patients enrolled

    Trial Details

    Trial ID

    NCT01204593

    Start Date

    November 1 2010

    End Date

    January 1 2013

    Last Update

    March 17 2014

    Active Locations (43)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 11 (43 locations)

    1

    Investigational Site Number 01201

    Algeries, Algeria

    2

    Investigational Site Number 01202

    Algiers, Algeria

    3

    Investigational Site Number 01203

    Algiers, Algeria

    4

    Investigational Site Number 01204

    Algiers, Algeria