Efficacy and Safety of Semaglutide Injection (HD1916) in Patients With Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 3) is built around Semaglutide.

Ozempic® in patients with type 2 diabetes mellitus (T2DM) with poor blood glucose control after metformin treatment.

It had two arms (groups): Semaglutide injection (HD1916) (experimental) and Ozempic® (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 506 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, age ≥ 18 years and ≤75 years old;. Patients diagnosed with type 2 diabetes;. At the time of screening, BMI≥18.5 kg/m\^2 and ≤35 kg/m\^2;. The patient is able to understand the informed consent form, voluntarily participate in the trial and sign the informed consent form.

The full record lists 7 inclusion and 36 exclusion criteria; among the exclusions: patients with type 1 diabetes or other special types of diabetes;; patients who meet the contraindications of glp-1 ra drugs and metformin hydrochloride drugs;; known allergy to the investigational drugs or excipients;.

How the Study Was Run

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

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

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

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

It started in 2024-02-23 with completion listed for 2025-05-14.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline to week 32 in glycosylated haemoglobin (HbA1c) (time frame: Week 32).

It also tracked 9 secondary outcomes, for example Change from baseline to week 20 in HbA1c, Change from baseline to week 20, 32 in fasting blood glucose, Change from baseline to week 20, 32 in body weight, Change from baseline to week 20, 32 in postprandial blood glucose, Percentage of participants who were offered rescue medication at week 20 and Incidence and severity of adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 506 people.

With 506 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 Semaglutide compound page, all human trials.