A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

This is a randomised, double-blind, four-period crossover euglycaemic clamp trial in subjects with type 2 diabetes.

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

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Humalog® Mix25 (active comparator).

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.

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

Enrollment: 40 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). Treated with a stable insulin regimen for ≥ 3 months prior to screening.

The full record lists 5 inclusion and 8 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; clinically relevant comorbidity, capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data; heart rate at rest outside the range of 50-90 beats per minute.

How the Study Was Run

Design: randomized, crossover and double-blind.

Because people in this Insulin Lispro 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 Lispro and the comparison in turn, acting as their own control.

As a double-blind Insulin Lispro 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 2023-01-02.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUCTOTAL0-last (time frame: From t=0 to t=30 hours after IMP administration). CmaxTOTAL (time frame: From t=0 to t=30 hours after IMP administration).

It also tracked 41 secondary outcomes, for example AUCGIR 0-last, GIRmax, tGIRmax, Tonset of action, AUCGIR 0-6h and AUCTOTALlast.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 40 people.

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.