Official Title: “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”

Primary: To assess 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.

Secondary:

To compare insulin glulisine, insulin aspart and insulin lispro on: - Unexplained hyperglycemia - Infusion set occlusion - HbA1c, hypoglycemic episodes, 7-point blood glucose profiles, episodes of ketosis and ketoacidosis - Insulin doses (total, basal, bolus) - Time to change the infusion set. - Site infection, site inflammation / erythema, pruritis and isolated pain at injection site - Overall safety: incidence of adverse events - Change in body weight

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: Insulin glulisine
  • 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
• Drug: Insulin lispro
  • 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
• Drug: Insulin aspart
  • 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2
• Active Comparator: 3

Primary Measures

• Episodes of unexplained hyperglycemia
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: No

Secondary Measures

• Episodes of infusion set occlusion.
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: No
• Time to change the infusion set and reservoir
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: No
• Local infection requiring drainage
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: No
• Adverse events, vital signs
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: Yes
• Laboratory Fasting Plasma Glucose (FPG) and HbA1c, Body weight
  • Time Frame: At week 0, week 13, week 26 and week 39
    Safety Issue?: No
• Insulin doses
  • Time Frame: At specific time points
    Safety Issue?: No
• Self-monitored blood glucose values
  • Time Frame: At specific time points
    Safety Issue?: No
• Episodes of ketosis and diabetes ketoacidosis
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: No
• Hypoglycemia
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: No

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 ophtalmoscopic 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Bertrand Alexandre, MD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00607087

Study ID Number: APIDR_C_02083

ClinicalTrials.gov Identifier: NCT00607087

Health Authority: Sweden: Regional Ethical Review Board