At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Insulin glulisine, Insulin lispro, and 1 other intervention for Diabetes Mellitus, Type 1. Completed, enrolled 289 participants across 12 sites in 12 countries.
Detailed 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
Study Details
Timeline
Interventions
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