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

Information source: Joslin Diabetes Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: insulin Aspart versus insulin Lispro (Drug); insulin pump (Device)

Phase: N/A

Status: Terminated

Sponsored by: Joslin Diabetes Center

Official(s) and/or principal investigator(s):
Howard A Wolpert, MD, Principal Investigator, Affiliation: Joslin Diabetes Center

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 Details

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

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

Primary outcome: Glycemic stability

Secondary outcome: Frequency of catheter change

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 1 diabetes treated with CSII at least 3 months.

- Males and females, > 18 years but < 75 years old.

- Hemoglobin A1c ≤ 8. 0 % at measurement taken at week 0 (screening visit).

- Duration of diabetes ≥ 12 months.

- Willingness to perform self-blood glucose monitoring several times/day.

Exclusion Criteria:

- Previous insulin precipitation in pump infusion catheters.

- Daily insulin requirements > 25% of pump reservoir capacity. (This would preclude the

subject from using the pump infusion system for more than 3 days).

- Use of an insulin pump that does not have a downloadable record of basal and bolus

doses.

- Known or suspected allergy to trial products.

- Pregnancy, breast-feeding, intention to become pregnant or inadequate contraception

measures.

- Known or suspected alcohol or drug abuse.

- Impaired renal function with creatinine ≥ 1. 7 mg/dl.

- Pronounced catheter site scarring.

- Chronic use of drugs that may influence glycemic control (e. g. steroids).

- Any other significant concomitant disease that would interfere with participation in

and completion of the trial.

Locations and Contacts

Joslin Diabetes Center, Boston, Massachusetts 02215, United States
Additional Information

Starting date: February 2007
Last updated: December 27, 2012

Page last updated: August 23, 2015

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