Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 2 trial tested Dulaglutide.

Approximately 225 participants will be randomized.

It had five arms (groups): HEC88473 dose1 (experimental), HEC88473 dose2 (experimental), HEC88473 dose3 (experimental), Placebo (placebo comparator) and Dulaglutide (active comparator).

The registry classes the interventions as drug.

Who Took Part

234 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 patients 18 to 75 years of age, inclusive. Have T2DM for at least 3 months before screening based on the disease diagnostic criteria (WHO 1999).

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have a personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men2) at screening; have serum calcitonin ≥20 ng/l at screening.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Dulaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-12-10 with completion listed for 2025-02-27.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline of HbA1c at week 12 (time frame: Baseline to week 12).

It also tracked 3 secondary outcomes, for example Change from baseline of weight at week 12, Change from baseline of fasting blood-glucose at week 12 and Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 234 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dulaglutide compound page, all human trials.