Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and 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

The registry lists 550 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: Male or female participants, 18 to 75 years of age at informed consent (inclusive). BMI between 18.0 and 30.0 kg/m² (inclusive). T1DM diagnosed ≥6 months per WHO diabetes classification (2019). On insulin therapy ≥6 months prior to screening. Stable insulin regimen ≥3 months prior to screening (no change in insulin class), with or without metformin or alpha-glucosidase inhibitors; willing to follow multiple daily injections:.

The full record lists 8 inclusion and 13 exclusion criteria; among the exclusions: diabetes other than t1dm; history of pancreatectomy; prior pancreatic and/or islet cell transplantation.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2022-04-13 with completion listed for 2025-01-23.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from Baseline in HbA1c at Week 26 (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 Glargine and Insulin Lispro in 550 people.

With 550 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 Glargine compound page and the Insulin Lispro compound page, all human trials.