Comparison of Insulins Aspart and Lispro in Insulin Pumps

What Was Tested

This registered phase 4 trial tested Insulin Aspart and Insulin Lispro.

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.

It had two arms (groups): Insulin 1 (active comparator) and Insulin 2 (active comparator).

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

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.

The registry classes the interventions as drug.

More on the Plan

Continuous subcutaneous insulin infusion (Insulin pump therapy) is a well established tool for the management of type 1 diabetes.

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.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 1 Diabetes treated with a pump for at least 3 months.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: inability to give informed consent; known or suspected hypersensitivity to trial drugs or any of their components.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2004-10 with completion listed for 2007-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Glycemic Control (Glucose Levels Between [amount hidden]/dL) 24 to 100 Hours After Line Change.

It also tracked 2 secondary outcomes, for example Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place and Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Lispro in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page and the Insulin Lispro compound page, all human trials.