Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal

What Was Tested

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

The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.

It had two arms (groups): Biochaperone Insulin Lispro (experimental) and Humalog® (active comparator).

The registry classes the interventions as drug.

Who Took Part

38 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 ≥ 12 months. Treated with multiple daily insulin injections or CSII ≥ 12 months. BMI 18.5-28.0 kg/m² (both inclusive).

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: type 2 diabetes mellitus; receipt of any trial product within 60 days prior to this trial; known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.

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.

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 and investigator.

It started in 2015-01 with completion listed for 2015-06.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the blood glucose time curve: AUCbg(0-2h) (time frame: 2 hours).

It also tracked 5 secondary outcomes, for example Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 38 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.