Comparison of Insulins Aspart and Lispro in Insulin Pumps

NCT ID: NCT00461331

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2008-08-31

Brief Summary

The purpose of the study is to 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.

Detailed Description

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 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 1,5-anhydroglucitol.

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Insulin 1

Either insulin Aspart or insulin Lispro were randomized to be insulin 1.

Group Type: ACTIVE_COMPARATOR

Insulin Aspart

Intervention Type: DRUG

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.

Insulin 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.

Group Type: ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type: DRUG

Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2.

Interventions

Insulin Aspart

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.

Intervention Type: DRUG

Insulin Lispro

Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2.

Intervention Type: DRUG

Other Intervention Names

Insulin lispro - insulin Humalog; Insulin aspart - insulin Novolog; Insulin Aspart

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tulane University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vivian A Fonseca, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Tulane Universtiy Health Sciences Center

Locations

Clinical Translational Unit - Tulane School of Medicine

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

F-0215

Identifier Type: -

Identifier Source: org_study_id