A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes

What Was Tested

The trial (phase 2) is built around Insulin Lispro.

The addition of BioChaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.

This is a double-blinded, randomised, four-period crossover phase 2 trial using automated 12-hour euglycemic clamps in subject with type 1 diabetes mellitus.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

38 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 12 months. Treated with multiple daily insulin injections of insulin pump for at least 12 months. Body Mass Index (BMI): 18.5-28.0 Kg.m².

The full record lists 3 inclusion and 7 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 as per investigator's judgement.

How the Study Was Run

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

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

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, care provider, investigator and outcomes assessor.

It started in 2014-05 with completion listed for 2014-07.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glucodynamic endpoint: Area Under the Curve GIR(0-last) (time frame: 12 hours). Glucodynamic endpoint: GIRMax (time frame: 12 hours).

It also tracked 4 secondary outcomes, for example Glucodynamic: TGIRmax, Tonset of action and Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters.

What This Means in Plain Language

Put simply, this is a phase 2, 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.