A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects With Type 1 Diabetes

What Was Tested

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

It had three arms (groups): BC Combo THDB0207 (experimental), Lantus® (active comparator) and Humalog® (active comparator).

Single administration of BC Combo THDB0207.

Single administration of Lantus®.

Single administration of Humalog®.

The registry classes the interventions as drug.

More on the Plan

Subjects will attend the study site in the morning in a fasted state and will be connected to an automated glucose clamp device (ClampArt).

IMP administration will be done by an unblinded person by means of subcutaneous injections in the abdominal wall.

Plasma insulin concentrations will be measured using a specific validated bioanalytical method differentiating concentrations of insulin glargine, of its main metabolites insulin glargine-M1 and insulin glargine-M2, and of insulin lispro.

Who Took Part

30 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 1 diabetes mellitus (as diagnosed clinically) for ≥ 12 months. BMI between 20.0 and 29.9 kg/m2 (both inclusive). Treated with insulin regimen for ≥ 12 months prior to screening.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: known or suspected hypersensitivity to the imps or any of the excipients or to any component of the imp formulation; type 2 diabetes mellitus; use of oral antidiabetic drugs (oads) and/or glp-1 receptor agonists (e.g. exenatide, liraglutide).

How the Study Was Run

It was run as a randomized, crossover and double-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 and investigator.

It started in 2022-05-12 with completion listed for 2022-10-28.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): AUCGIR 0-6h (time frame: From t=0 to t=6 hours after IMP administration). AUCGIR 6-24h (time frame: From t=6 to t=24 hours after IMP administration).

It also tracked 18 secondary outcomes, for example AUCGIR 0-last, AUCGIR 0-4h, GIRmax, tGIRmax, tonset of action and AUCINS 0-6h.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine and Insulin Lispro in 30 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.