To Investigate the Efficacy and Safety of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro compared to Humalog®.

The meal tolerance test will be performed on day 1-3 and on day 14 of each period.

It had two arms (groups): BioChaperone insulin lispro (experimental) and Humalog® (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 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: Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months. Treated with multiple daily insulin injections (no pump users) ≥ 12 months. Body mass index (BMI) 18.5-28.0 kg/m² (both inclusive).

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial products or related products; type 2 diabetes mellitus; patients using continuous subcutaneous insulin infusion (csii).

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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

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

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, care provider, investigator and outcomes assessor.

It started in 2015-08 with completion listed for 2015-12.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUCΔBG0-2h (timepoint 0 = administration of the meal) (time frame: 2 hours).

It also tracked 7 secondary outcomes, for example AUClispro_0-6h, Cmax_lispro, Tmax_lispro, AUCBG_0-6h, ΔBGmax and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 36 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.