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

• Status: Completed
• Trial end date: 2009-06-01

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

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin glulisine; Insulin Lispro; Insulin, Globin Zinc; Insulin, Long-Acting