A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Lispro.

BC106 is a molecule that when injected with insulin lispro may change the speed of absorption of insulin lispro.

It had two arms (groups): Insulin Lispro (active comparator) and BC106 Insulin Lispro (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 37 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin including allergies to dextrans; have a history of first-degree relatives known to have diabetes mellitus; have used systemic glucocorticoids within 3 months prior to entry into the study.

How the Study Was Run

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

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

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

Only one side, usually the participants, was kept unaware of whether Insulin Lispro was given.

Those kept unaware of assignments: participant.

It started in 2012-07 with completion listed for 2012-09.

It ran at 1 site in Singapore.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 3 secondary outcomes, for example Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro and Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 37 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.