Semaglutide's Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy

What Was Tested

In this not phased trial, researchers set out to test Semaglutide.

The goal of this double-blinded, placebo-controlled, randomized, crossover study is to examine the effect of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), on renal hemodynamics and function in patients with type 2 diabetes mellitus (T2DM) and moderate chronic kidney disease (CKD).

The study will determine the effects of semaglutide on: * Renal arterial blood flow, regional renal perfusion, and oxygenation * Activity of the renin-angiotensin-aldosterone system (RAAS) * The glomerular filtration rate (GFR) * Sodium excretion in urine * Blood pressure and heart rate.

It had two arms (groups): Randomized to start with Semaglutide intervention in study period 1 (other) and Randomized to start with Placebo intervention in study period 1 (other).

Placebo will be given in study period 2.

Semaglutide will be given in study period 2.

The registry classes the interventions as drug.

More on the Plan

The expansion of extracellular fluid volume uncovers a natriuretic action of GLP-1.

The aim of the present study is to investigate possible mechanisms behind the renal effects of semaglutide in patients with type 2 diabetes mellitus and moderate chronic kidney disease.

This is a double-blinded, placebo-controlled, crossover study and patients will participate in two independent and randomized study periods with a washout period of around 4 weeks in between.

Fifteen male participants with type 2 diabetes mellitus in the age group 20-60 years are screened, randomized, and expected to complete the present study.

Who Took Part

The registry lists 15 planned participants were the target.

It was open to men only aged from 20 years up to 60 years.

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

Examples of who could join: Stable RAAS blockade (ACE inhibitors or angiotensin II receptor blocker (ARB) with stable dosis for 4 weeks prior to screening). Discontinuation of treatment with selective sodium glucose transporter inhibitors (SGLT2i), dipeptidyl peptidase 4 inhibitors (DPP-4i), GLP-1R analogs, rapid-acting and mix insulin 30 days before screening.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: immunosuppressive therapy within 30 days of screening; alcohol abuse; medical treatment with glucocorticoids.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Semaglutide and the comparison in turn, acting as their own control.

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 and investigator.

It started in 2024-08 with completion listed for 2025-03.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Total blood flow. Regional renal perfusion.

It also tracked 5 secondary outcomes, for example Glomerular filtration rate, Sodium excretion in urine, Activation of the renin angiotensin aldosterone system, Blood pressure and Heart Rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 15 people.

Its size is small, so on its own it can only give an early look.

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.