Glycemic Stability of Insulin Aspart Versus Insulin Lispro in Insulin Pump Therapy

Type 1 Diabetes Mellitus Clinical Trial

Official title: Glycemic Stability of Insulin Aspart Versus Insulin Lispro in Insulin Pump Therapy

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine:

1. whether there is a difference between insulin aspart and insulin lispro in continuous insulin pump therapy

2. whether duration of the insulin infusion set placement effect blood sugar control if the infusion set is in place for longer then 72-96 hours

Clinical Trial Description

Insulin instability in pump infusion systems can result in unexplained hyperglycemia in patients on continuous subcutaneous insulin infusion (CSII) therapy. We have noted that some pump patients develop glycemic instability with use of insulin lispro, and that this resolves with change to insulin aspart. Several patients using lispro have reported noting a whitish precipitate in the infusion set, and in two cases we have examined the catheters and confirmed biochemically that this precipitate was insulin. Furthermore, in vitro studies indicate that insulin aspart is more resistant to isoelectric precipitation than insulin lispro. Although it has been rare for patients to notice a visible precipitate in the pump catheter, there is a subset of patients using lispro who have noted that their blood glucose levels will tend to rise 2 or more days after the insertion of a new pump infusion system. These findings mirror bench studies showing that the relative stability differences between aspart and lispro in pump infusion systems becomes more apparent over time.

The endpoints examined in previous randomized clinical trials comparing aspart and lispro were not directed specifically at assessing the effect of insulin type on glycemic stability. In these previous studies, pump infusion systems were changed every 48 hours whereas most pump patients routinely replace their infusion catheters only every 72-96 hours; this discrepancy may account for the failure of these trials to demonstrate the difference in the stability of insulin aspart and lispro that has been noted in clinical practice.

This investigator-initiated clinical trial is intended to assess the safety and efficacy of CSII with insulin aspart compared to insulin lispro with use of pump infusion catheters for up to 96 hours. ;

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

• NCT number: NCT00428207
• Study type: Interventional
• Source: Joslin Diabetes Center
• Status: Terminated
• Phase: N/A
• Start date: February 2007
• Completion date: August 2008