A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

What Was Tested

The trial (phase 1) 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 a facilitation of the absorption of the insulin after subcutaneous injection.

This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus.

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

BioChaperone insulin lispro.

Humalog®.

The registry classes the interventions as drug.

Who Took Part

The registry lists 37 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 or insulin pump for at least 12 months. Body Mass Index (BMI): 18.0-28.0 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 double-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.

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 2013-12 with completion listed for 2014-03.

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 curve (AUC) (time frame: 30 minutes).

It also tracked 7 secondary outcomes, for example Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours, Glucodynamics: Early t0.5(GIRmax), Glucodynamic: GIRmax (Maximum glucose infusion rate) and 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 37 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.