Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Lispro.

This is a 26-week randomized, open-label, multicenter, active-controlled parallel group trial.

It had two arms (groups): THDB0206 Injection (experimental) and Insulin Lispro Injection (active comparator).

The registry classes the interventions as drug.

Who Took Part

1040 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Body mass index: 18.0 kg/m\^2\~35.0 kg/m\^2 (both inclusive) at the time of screening. Diagnosed with T2DM for 6 months or longer at the time of screening based on the World Health Organization (WHO) classification. Treated with stable insulin regimen as follow for at least 3 months with or without oral antidiabetic drug:. Basal insulin (neutral protamine Hagedorn \[NPH\] insulin, insulin glargine, insulin degludec, insulin detemir) in combination with at least 1 prandial injection of bolus insulin. Premixed insulin at least twice daily.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: have other types of diabetes other than t2dm; have used glucagon-like peptide 1 (glp-1) receptor agonist within 3 months prior to screening; have had 1 or more episodes of severe hypoglycemia within the 6 months prior to screening.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

The Insulin Lispro group and the comparison group ran side by side rather than switching.

Everyone knew when Insulin Lispro was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-05-06 with completion listed for 2024-12-10.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment (time frame: Week 26).

It also tracked 2 secondary outcomes, for example Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26 and Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro in 1040 people.

With 1040 participants it is a large trial for this field.

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.