A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro.

This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus.

It had two arms (groups): A (experimental) and B (active comparator).

Drug: BioChaperone® Combo.

Drug: Humalog® Mix25.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 21 actual participants took part.

It was open to men only aged from 18 years up to 64 years.

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

Examples of who could join: Type 1 diabetes mellitus for at least (or equal to ) 12 months,. Treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,. Body Mass Index (BMI): 18.0-28.0kg/m2 (both inclusive).

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: type 2 diabetes mellitus,; any systemic treatment with drugs known to interfere with glucose metabolism,; history of alcoholism or drug/chemical abuse and any tobacco product within 5 years prior to screening.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Insulin Lispro, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2013-11 with completion listed for 2013-12.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Number of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 21 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.