A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

This is a single-centre, randomised, double-blind, 4-way crossover, 4-treatment, euglycaemic clamp study in subjects with Type 1 Diabetes Mellitus (T1DM).

Each subject will be randomly allocated to one of four treatment sequences.

It had four arms (groups): BioChaperone insulin lispro reconstituted with Humalog® (IMP1) (experimental), Ready-to-use BioChaperone insulin lispro (IMP2) (experimental), US-approved Humalog® (IMP3) (active comparator) and EU-approved Humalog® (IMP4) (active comparator).

The registry classes the interventions as drug.

Who Took Part

32 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Subjects with type 1 Diabetes Mellitus. Body Mass Index (BMI) between 18.5 and 28.5 kg/m\^2, both inclusive.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: known or suspected hypersensitivity to imp(s) or related products; history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction; any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the investigator.

How the Study Was Run

It was run as a randomized, crossover and quadruple-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.

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-08-03 with completion listed for 2020-11-03.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: AUCGIR.0-12h (time frame: From t=0 to t=12 hours after IMP administration). AUCGIR.0-1h (time frame: From t=0 to t=1 hour after IMP administration). AUCLIS.0-12h (time frame: From t=0 to t=12 hours after IMP administration).

It also tracked 7 secondary outcomes, for example tmax.LIS, Cmax.LIS, AUCLIS.2-6h, tmax.GIR, GIRmax and AUCGIR.4-8h.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 32 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.