A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Insulin Lispro.

The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection.

This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus.

It had three arms (groups): BioChaperone human insulin (experimental), Human insulin (active comparator) and Insulin lispro (active comparator).

BioChaperone Human Insulin.

Huminsulin® Normal.

Humalog®.

The registry classes the interventions as drug.

Who Took Part

The registry lists 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: Male subject with type 1 diabetes for at least 12 months. Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months. Body mass index: 18.5-28.0 kg BW·m-2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: diabetes mellitus type 2; 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

It was run as a randomized, crossover and quadruple-blind study.

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 2014-08 with completion listed for 2014-12.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the curve (AUCins(0-1h)) (time frame: 1 hour).

It also tracked 9 secondary outcomes, for example Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours, Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax), Glucodynamics: GIRmax - Maximum glucose infusion rate, Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters and Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours.

What This Means in Plain Language

Put simply, this is a phase 1, 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.