A Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus

What Was Tested

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

Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-BioChaperone insulin lispro.

Injections will take place immediately before an individualised standard meal in the morning of day 1, 2, 13, and 14.

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

The registry classes the interventions as drug.

Who Took Part

51 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Type 2 diabetes mellitus ≥ 12 months. Treated with stable multiple daily insulin ≥ 3 months (basal-bolus therapy or only bolus insulin therapy). Body Mass Index below or equal to 40.0 kg/m².

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial products or related products; type 1 diabetes mellitus; previous participation in this trial.

How the Study Was Run

Design: randomized, crossover and triple-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Lispro.

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

It started in 2015-09 with completion listed for 2016-01.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example AUClisp_0-6h, Cmax_lisp, tmax_lisp, CmaxBG, AUCBG_0-6h and Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 51 people.

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.