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

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

Timeline

Start

2008-01

Primary completion

2009-06

Completion

2009-06

Publications

• van Bon AC, Bode BW, Sert-Langeron C, DeVries JH, Charpentier G. Insulin glulisine compared to insulin aspart and to insulin lispro administered by continuous subcutaneous insulin infusion in patients with type 1 diabetes: a randomized controlled trial. Diabetes Technol Ther. 2011 Jun;13(6):607-14. doi: 10.1089/dia.2010.0224. Epub 2011 Apr 2.

Drugs

Indications