A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Semaglutide.

The study compares two semaglutide medicines and looks at how well they control blood sugar levels, in participants with type 2 diabetes (T2D).

Participants will either get the currently available semaglutide or the semaglutide which is produced through a new manufacturing process.

Participants need to take one injection of semaglutide once a week, on the same day of every week.

It had two arms (groups): Semaglutide J (experimental) and Semaglutide B (active comparator).

The registry classes the interventions as drug.

Who Took Part

388 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study intervention(s) or related products.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind 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.

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

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

It started in 2022-08-03 with completion listed for 2023-08-09.

It ran at 104 sites in United States (55), Canada (21), Poland (12), South Africa (9) and Slovakia (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of treatment (week 28)).

It also tracked 8 secondary outcomes, for example Change in Body Weight, Number of Treatment-Emergent Adverse Events (TEAEs), Occurrence of Anti-semaglutide Antibodies (Yes/no), Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no), Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no) and Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 388 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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