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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 — PUMP  

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

The maximal duration of the study participation for patients was 41 weeks and one day, split in:

- a 2-week screening period,

- a 39-week treatment period: 3 treatment periods of 13 weeks with a crossover alternative regimen, including a dose adjustment period of 1 week at the beginning of each period (sequence1: insulin glulisine, then insulin aspart, then insulin lispro; sequence2: insulin aspart, then insulin lispro, then insulin glulisine; sequence 3: insulin lispro, then insulin glulisine, then insulin aspart)

- and a follow-up period of 24 hours. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00607087
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 4
Start date January 2008
Completion date June 2009
View Details
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