Absorption of Insulin Following Subcutaneous Bolus Administration With Different Bolus Durations

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

To cover meal-related insulin requirements, insulin pumps allow insulin to be delivered at high rates over a short period of time (bolus delivery).

The length of this period (bolus duration) usually depends on the chosen bolus size and on the used insulin pump model.

It had two arms (groups): 1 bolus of insulin lispro with short bolus duration (experimental) and 1 bolus of insulin lispro with long bolus duration (experimental).

The registry classes the interventions as drug.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Informed consent obtained after being advised of the nature of the study. Male or female aged 18-60 years (both inclusive). Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months. Body mass index 20.0-30.0 kg/m² (both inclusive).

The full record lists 6 inclusion and 19 exclusion criteria; among the exclusions: female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods; skin pathology or condition prohibiting needle insertion/insulin administration as judged by the investigator; history of bleeding disorder.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Insulin Lispro study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2011-08 with completion listed for 2011-11.

It ran at 1 site in Austria.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): tmax(GIR); time to maximum glucose infusion rate (time frame: 8 hours).

It also tracked 1 secondary outcome, for example GIRmax, maximum glucose infusion rate.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of 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; no results are posted to the registry yet, so nothing here describes outcomes.

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