A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes

What Was Tested

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

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

Individualised simultaneous subcutaneous injections.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female subject aged 18-70 years (both inclusive). Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months. Body mass index between 20.0 and 40.0 kg/m2 (both inclusive). Treated with once daily injections with insulin glargine U-100 for ≥ 3 months prior to screening.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: type 1 diabetes mellitus; known or suspected allergy to the imps or related products; previous participation in this trial. participation is defined as randomised.

How the Study Was Run

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

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

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, investigator and outcomes assessor.

It started in 2016-10 with completion listed for 2017-06.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Delta AUC BG 0-2h (area under the blood glucose concentration-time curve) (time frame: From 0 to 2 hours).

It also tracked 10 secondary outcomes, for example Partial delta AUCs BG and total AUCs BG, Mean and mean change from baseline of blood glucose at different time points, Delta BGmax and delta BGmin, BGmax and BGmin, AUC Insulin and Cmax Insulin.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine and Insulin Lispro in 36 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.