Analyse the Effect of Semaglutide on Vascular Structure and Function in Patients With Early Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide.

At least 90 patients will be randomized (1:1) and included (informed consent, intention to treat population) in order to obtain 80 fully evaluable subjects (per protocol population).

It had two arms (groups): Treatment (active comparator) and Placebo (placebo comparator).

Baseline vascular function parameters will be obtained and the patient will be given placebo (SC, administered by personal injector, once weekly).

The registry classes the interventions as drug.

More on the Plan

Diabetes mellitus type 2, considered at the beginning as a metabolic disorder, converts into a predominantly vascular disease, once its duration extends over several years or/and when additional cardiovascular risk factors like arterial hypertension coexist.

In the PIONEER-6 study conducted in patients with type 2 diabetes at least above 50 years with cardiovascular or chronic kidney disease or above 60 years and with cardiovascular risk factors, oral semaglutide proved cardiovascular safety.

In accordance, central pulse pressure has been repeatedly found to independently predict cardiovascular morbidity and mortality in various study cohorts.

Further-more, prospective data have now been published showing that the forward and backward (reflected) wave amplitude predict independently cardiovascular complications.

Who Took Part

Enrollment: 107 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: Age of 18 - 75 years. Male and Female patients (females of child bearing potential must be using adequate contraceptive precautions). Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit. Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form.

The full record lists 6 inclusion and 25 exclusion criteria; among the exclusions: any other form of diabetes mellitus than type 2 diabetes mellitus; use of insulin, sulfonylurea or glp-1 analogue within the past 3 months; patients with more than two oral blood glucose lowering medication.

How the Study Was Run

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

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.

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 2022-03-03 with completion listed for 2023-12-15.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Central (aortic) pulse pressure assessed by Sphygmocor XCEL (time frame: 16 weeks).

It also tracked 14 secondary outcomes, for example Central (aortic) systolic pressure assessed by Sphygmocor XCEL, Augmentation pressure assessed by Sphygmocor XCEL, Augmentation index (cAIX@75) assessed by Sphygmocor XCEL, Forward wave amplitude assessed by Sphygmocor XCEL, Backward wave amplitude assessed by Sphygmocor XCEL and Outer diameter of small retinal arterioles assessed by Scanning laser Doppler flowmetry.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 107 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.