Semaglutide Anti-Atherosclerotic Mechanisms of Action Study in Type 2 Diabetes Patients

What Was Tested

This registered not phased trial tested Semaglutide.

Diabetes is a chronic disease characterized by chronic hyperglycaemia, causing microvascular and macrovascular complications.

The latter lead to various disabilities: blindness, end-stage renal failure, nerve damage, formation of leg ulcers, and atherosclerosis.

In people with type 2 diabetes, the probability of these atherosclerosis associated complications is twice as high as in people without diabetes.

It had two arms (groups): Interventional Arm (active comparator) and Comparative Arm (no intervention).

This group will not be receiving the additional therapy besides metformin and sulphonyl urea treatment. After 6 months a revaluation of glycemic control will be performed, if needed, rescue therapy with basal insulin will be implemented.

The registry classes the interventions as drug.

Who Took Part

100 planned participants were the target.

It was open to people of any sex aged from 30 years up to 60 years.

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

Examples of who could join: Type 2 diabetes. BMI \> or = 30 kg/m2. Associated risk factors including smoking, dyslipidaemia, arterial hypertension, chronic kidney disease stage 1 to 3.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: therapy with injectable glp-1 receptor agonist ongoing or was taking place in the last year; manifested cardiovascular disease; heart failure.

How the Study Was Run

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

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, investigator and outcomes assessor.

It started in 2022-05-01 with completion listed for 2023-05-01.

It ran at 1 site in Slovenia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in morphological arterial wall characteristics (time frame: 1 year). Change in functional arterial wall characteristics (time frame: 1 year). Change in structural arterial wall characteristics (time frame: 1 year).

It also tracked 4 secondary outcomes, for example Change in atherogenic small dense low-density lipoproteins (sdLDL), Change in glycated haemoglobin (HbA1c) and Change in high sensitivity C-reactive protein (hsCRP).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 100 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.