A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 1) is built around Insulin Glargine and Insulin Lispro.

This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin treatment.

It had three arms (groups): Biochaperone Combo (experimental), Humalog Mix25 (active comparator) and Humalog and Lantus (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 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 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months. Body mass index between 20.0 and 35.0 kg/m2 (both inclusive). Body weight ≤ 125.0 kg. Treated with a stable insulin regimen for ≥ 3 months prior to screening.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: type 1 diabetes mellitus; known or suspected allergy to the trial products or related products; previous participation in this trial. participation is defined as randomised.

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

As a double-blind Insulin Glargine 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 2015-07 with completion listed for 2015-11.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 10 secondary outcomes, for example tGIRmax, AUCLis 0-30h, AUCGla 0-30h, tmax Gla, tmax Lis and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine and Insulin Lispro in 24 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 Glargine compound page and the Insulin Lispro compound page, all human trials.