Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin glulisine; Insulin lispro; Insulin aspart
Intervention description: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump; 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump; 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro; Insulin glulisine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 289.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart
      and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or
      infusion set occlusion.

      Main Secondary objectives:

      To compare insulin glulisine, insulin aspart and insulin lispro on:

        -  Unexplained hyperglycemia

        -  Infusion set occlusion

        -  Hypoglycemic episodes,7-point blood glucose profiles

        -  Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis

        -  Time to change the infusion set

        -  HbA1c (Glycosylated hemoglobin)

        -  Overall safety: incidence of adverse events
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetic subjects

          -  Treated with insulin for at least 2 years and by CSII for at least 6 months

          -  Using the same insulin (insulin glulisine, insulin aspart or insulin lispro) in CSII
             for at least 3 months with the same external pump compatible with the 3 short acting
             insulin analogues used in the study

          -  Using the same type of infusion set (catheter and cannula) for at least 3 months

          -  Performing at least 3 blood glucose controls per day

          -  HbA1c < 8.5%

          -  Body mass index (BMI) < 35 kg/m²

          -  Ability and willingness to perform blood glucose and ketone monitoring using the
             Sponsor-provided combined glucose and ketone meter and patient diary at home

        Exclusion Criteria:

          -  Diabetes other than Type 1

          -  Total daily dose of insulin greater than 90 U/day

          -  Using an insulin pump requiring pre-filled cartridges

          -  History of infection at infusion site requiring a drainage in the last 3 months

          -  History of severe episodes of ketosis requiring hospitalization in the last 6 months

          -  Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy
             occurrence in the 6 months prior to visit 1, or any other unstable (rapidly
             progressing) retinopathy that may require photocoagulation or surgical treatment
             during the study. An ophthalmoscopic examination should have been performed in the 2
             years prior to study entry

          -  Pregnancy (women of childbearing potential must have a negative pregnancy test at
             study entry and a medically approved contraception method) or breastfeeding

          -  Treatment with systemic corticosteroids or medication known to influence insulin
             sensitivity in the 3 months prior to visit 1

          -  Treatment with antidiabetic drug other than insulin in the 3 months prior to visit 1

          -  Likelihood of requiring treatments during the study which are not permitted

          -  Treatment with an investigational product in the 30 days prior to visit 1

          -  History of sensitivity to the study drugs or to drugs with a similar chemical
             structure

          -  Presence of any condition (medical, including clinically significant abnormal
             laboratory test, psychological, social or geographical) actual or anticipated that the
             Investigator feels would compromise the patient safety or limit his/her successful
             participation in the study

          -  Night shift workers

          -  Impaired renal function as shown by serum creatinine ≥1.5 mg/dL (133 μmol/L) or ≥1.4
             mg/dL (124 μmol/L) in men and women, respectively

          -  Impaired hepatic function as shown by Alanine aminotransferase (ALT) and/or Aspart
             aminotransferase (AST) greater than three times the upper limit of normal range)

          -  Alcohol or drug abuse in the last year

          -  Mental condition rendering the patient unable to understand the nature, scope and
             possible consequences of the study

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.