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

What Was Tested

The trial (not phased) is built around Insulin Aspart and Insulin Lispro.

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.

It had two arms (groups): Insulin Aspart Versus Insulin Lispro (active comparator) and Insulin Lispro Versus Insulin Aspart (active comparator).

The registry classes the interventions as drug.

More on the Plan

Insulin instability in pump infusion systems can result in unexplained hyperglycemia in patients on continuous subcutaneous insulin infusion (CSII) therapy.

The researchers 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 the researchers 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.

Who Took Part

Enrollment: 4 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: Males and females, \> 18 years but \< 75 years old. Willingness to perform self-blood glucose monitoring several times/day.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: previous insulin precipitation in pump infusion catheters; known or suspected allergy to trial products; pregnancy, breast-feeding, intention to become pregnant or inadequate contraception measures.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-02 with completion listed for 2008-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glycemic Stability (time frame: 48 to 96 hours).

It also tracked 1 secondary outcome, for example Frequency of Catheter Change.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart and Insulin Lispro in 4 people.

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

It ended early (terminated); 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.