A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight

What Was Tested

The trial (phase 2) is built around Semaglutide.

It had six arms (groups): one (experimental), one (placebo comparator), one (experimental), one (placebo comparator) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 245 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.

Examples of who could join: Male or female. Aged 18-64 years (both inclusive) at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus greater than equal to (≥) 180 days prior to the day of screening. Glycosylated haemoglobin (HbA1c) of 7.0 - 10.5 percentage (%) \[53 - 91 millimoles per mole (mmol/mol)\] (both inclusive). Body Mass Index (BMI) ≥ 27.0 kilograms per meter square (kg/m\^2).

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: renal impairment measured as estimated glomerular filtration rate (egfr) value of less than (\<) 30 milliliters per minute (ml/min)/1.73 meter square (m\^2) at screening.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2022-08-08 with completion listed for 2023-10-12.

It ran at 130 sites in United States (101), Greece (12), Hungary (8), Poland (8) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycated Haemoglobin (HbA1c) (time frame: Baseline (week 0) and End of treatment (week 40)).

It also tracked 3 secondary outcomes, for example Change in Body Weight, Number of Treatment-emergent Adverse Events (TEAEs) and Number of Treatment-emergent Severe Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 245 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.