A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers

What Was Tested

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

This is a randomised, double-blind, double-dummy, active-controlled, three-period crossover euglycemic clamp trial in healthy Chinese volunteers.

Each subject will be randomly allocated to one of 6 treatment sequences.

It had three arms (groups): BC Combo THDB0207 (experimental), Humalog® Mix25 (active comparator) and Humalog® and Lantus® (active comparator).

Single administration of BC Combo THDB0207.

Single administration of Humalog® Mix25.

Simultaneous administration of Humalog® and Lantus®.

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

27 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: BMI between 18.5 and 30.0 kg/m2, both inclusive.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: known or suspected hypersensitivity to imp(s) or any of the excipients or to any component of the imp formulation; receipt of any investigational medicinal product within 3 months before randomisation in this trial; heart rate at rest outside the range of 50-90 beats per minute.

How the Study Was Run

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

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.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.

Those kept unaware of assignments: participant and investigator.

It started in 2022-05-12 with completion listed for 2022-12-04.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: AUCGIR 0-2h (time frame: From t=0 to t=2 hours after IMP administration).

It also tracked 19 secondary outcomes, for example AUCGIR 0-last, GIRmax, AUCGIR 0-1h, AUCGIR 0-6h, AUCGIR 0-24h and tGIRmax.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine and Insulin Lispro in 27 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.