A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM

What Was Tested

The trial (phase 3) is built around Dulaglutide and Ecnoglutide.

It had three arms (groups): B1: XW003+MET (experimental), B2: XW003+MET (experimental) and B3: Dulaglutide+MET (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 623 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: Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures. Sex: male or female; Age: 18 to 75 years, inclusive. BMI: 20.0 kg/m\^2 to 35.0 kg/m\^2, inclusive.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: history of type 1 or other types of diabetes mellitus; use of insulin during the 6 months preceding screening; history of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Dulaglutide and who got the comparison, which limits bias.

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

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

It started in 2023-01-10 with completion listed for 2024-07-03.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from baseline in HbA1c (time frame: Baseline, week 32).

It also tracked 5 secondary outcomes, for example Change from baseline in HbA1c, Change from baseline in fasting plasma glucose (FPG), Change from baseline in lipid panel and Change from baseline in body weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Dulaglutide and Ecnoglutide in 623 people.

With 623 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 Dulaglutide compound page and the Ecnoglutide compound page, all human trials.