Official Title: “A Comparison of the Efficacy Beyond 48 Hours of Insulin Aspart (Novolog) and Lispro (Humalog) in Insulin Pumps”

The purpose of the study is to study compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: June 2007

Continuous subcutaneous insulin infusion (Insulin pump therapy) is a well established tool for the management of type 1 diabetes. In clinical trials, insulin pump therapy has been shown to have increased efficacy over multiple daily injections. However, the overall glycemic control in patients using insulin pumps has been disappointing. The recommended duration of "needle use" in insulin pump treatment is 48 hours, based on anecdotal observations.

One of the reasons for the suboptimal control may be that patients do not adhere to the advice of changing their pump infusion line every 48 hours. However, it is possible that the loss of glycemic control may be related to instability of insulin in the pump/line. In addition to premeal loss of control after 48 hours of line change, very little is known about post-prandial hyperglycemia leading to loss of efficacy of the insulin via an insulin pump bolus. The development of continuous glucose monitoring system (CGMS)and new tests for short term fluctuations in glucose control such as 1,5-anhydroglucitol (glycomark) make it easier to evaluate the impact of short term loss of control in patients using the insulin pump who delay changing their lines.

The different variables will be compared between the two insulins using a paired t test.

1. Glycemic control will be will be compared 24 to 100 hours after pump infusion line change using CGMS and daily serum glycomark.

2. Post prandial glycemic excursions in plasma glucose following a standardized breakfast 48, 72, and 96 hours after a pump infusion line change will be compared.

3. The used pump infusion line will be collected from the patient and analyzed for insulin binding to the plastic, as well as other possible effects that may determine its role in loss of glycemic control.

4. Comparison of some of the markers of coagulation, inflammation, protein glycation and oxidative stress 48, 72, and 96 hours after a pump infusion line change.

Intervention(s) in this Clinical Trial

• Drug: Either Insulin Aspart or Lispro
  • Either one of these insulins were given to the patient as the second insulin (depending on which was given as the first one, the other insulin was insulin 2). Patients used this insulin in the same dose as they did prior to entering the study.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Either insulin Aspart or insulin Lispro were randomized to be insulin 1.
• Active Comparator: 2
  • Between insulin Aspart and insulin Lispro, the one that was not used as insulin 1 was then used as the second insulin for the second arm of the study.

Primary Measures

• Compare glycemic control between insulins Aspart and Lispro 24 to 100 hours after line change
  • Time Frame: 24 to 100 hours after last pump infusion line change
    Safety Issue?: Yes

Secondary Measures

• 1-Compare daily serum glycomark levels 48 to 100 hours after pump infusion line change
  • Time Frame: 24 to 100 hours after the last pump infusion line change
    Safety Issue?: No
• 2-Compare the changes in coagulation, inflammation, protein glycation and oxidative stress 48, 72 and 96 hours after pump infusion line change
  • Time Frame: 24 to 100 hours after the last pump infusion line change
    Safety Issue?: No
• Analysis of the pump infusion line more than 48 hours after pump infusion line change
  • Time Frame: 24 to 100 hours after the last pump infusion line change
    Safety Issue?: Yes

Inclusion Criteria:

• Type 1 Diabetes treated with a pump for at least 3 months

Exclusion Criteria:

• Pregnancy
• Plasma Creatinine > 1.2 mg/dl
• Inability to give informed consent
• HbA1c > 8%
• Known or suspected hypersensitivity to trial drugs or any of their components

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Tulane University Health Sciences Center

Overall Clinical Trial Officials and Contacts

Vivian A Fonseca, MD, FRCP Principal Investigator Tulane Universtiy Health Sciences Center  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00461331

Study ID Number: F-0215

ClinicalTrials.gov Identifier: NCT00461331

Health Authority: United States: Institutional Review Board