Efficacy and Safety of Semaglutide Ingection in Subjects With Type 2 Diabetes

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): QLG2065 (experimental) and Ozempic (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 478 planned participants were the target.

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 at the time of screening. Subjects diagnosed with type 2 diabetes for at least 6 months (WHO, 1999). BMI≥18.5kg/m2 and ≤35 kg/m2.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: known or suspected hypersensitivity to any glp-1ra or related products, or allergic constitution; treatment with glp-1ra, dpp-4 inhibitor, or insulin in a period of 60 days before screening. an exception is short-term insulin therapy (≤7 days in total); history of chronic or acute 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.

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 2023-07-10 with completion listed for 2024-11-24.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (time frame: Week 33).

It also tracked 5 secondary outcomes, for example Change in HbA1c, Change in Fasting Glucose and Change in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 478 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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