Efficacy and Safety of Semaglutide Injection vs Ozempic® in Patients With Type 2 Diabetes

What Was Tested

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

Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or Ozempic® injection abdominal subcutaneous injection will be given according to their groups weekly for 32 weeks.

Follow-up for 4 weeks after administration.

It had two arms (groups): Experimental group (experimental) and Active Comparator (active comparator).

The registry classes the interventions as drug.

Who Took Part

494 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 18-75 years (both inclusive) at the time of signing informed consent. BMI 18.5-35 kg/m2 (both inclusive).

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: other types of diabetes besides type 2 diabetes; A history of acute diabetes complications within 6 months before screening; A history of acute or chronic pancreatitis, symptomatic gallbladder disease, or other high-risk factors that may lead to pancreatitis.

How the Study Was Run

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

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

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 2023-09-20 with completion listed for 2024-10-11.

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 HbA1c from baseline (time frame: Week 32).

It also tracked 6 secondary outcomes, for example Change in HbA1c from baseline, Change in Fasting Plasma Glucose(FPG) from baseline, C-peptide and Insulin.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 494 people.

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.