A Study of the Efficacy and Safety of Semaglutide Injection in the Treatment of Type 2 Diabetes Mellitus

What Was Tested

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

Semaglutide injection is a new drug developed according to Ozempic® biosimilars.This trial is conducted in China.

It had two arms (groups): semaglutide injection (experimental) and ozempic® (active comparator).

The registry classes the interventions as biological.

More on the Plan

The study was divided into three phases: screening, baseline and treatment.

Who Took Part

476 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: Volunteer to participate in the trial and sign the informed consent form；. Male or female, Aged 18-75 years (both inclusive) at the time of signing informed consent；.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: systemic corticosteroids (excluding topical and inhaled preparations) within the past 90 days to the day of screening;; known or suspected hypersensitivity to trial product(s) or related products;; have participated in other clinical trials and used investigational drugs within the past 90 days to the day of screening;.

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.

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

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

It started in 2022-07-25 with completion listed for 2023-07-25.

It ran at 35 sites in China (35).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The observed mean change in Glycosylated Haemoglobin A1c (HbA1c) values from baseline after 32 weeks of treatment (time frame: 32 weeks).

It also tracked 10 secondary outcomes, for example The observed mean change in HbA1c values from baseline after 20 weeks of treatment, Change From Baseline to Week 20 in Fasting Plasma Glucose (FPG), Change From Baseline to Week 32 in Fasting Plasma Glucose (FPG), Change From Baseline to Week 32 in Body Weight (Kilogram (kg)), Change From Baseline to Week 32 in Systolic and Diastolic Blood Pressure and Change From Baseline to Week 32 in Pulse Rate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 476 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.