Effects of semaglutide, empagliflozin and their combination on renal diffusion-weighted MRI and total kidney volume in patients with type 2 diabetes: a post hoc analysis from a 32 week randomised trial

What Was Tested

This randomized controlled trial paper looks at Semaglutide.

The apparent diffusion coefficient (ADC) derived from diffusion-weighted MRI (DWI-MRI) has been proposed as a measure of changes in kidney microstructure, including kidney fibrosis.

Glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter 2 inhibitors both provide protection against progression of kidney disease in diabetes.

However, the mechanisms are incompletely understood.

Why It Was Studied

European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) 2019-000781-38.

Who Took Part

By PubMed's age tags, the people studied were middle-aged adults and older adults, both men and women.

Eighty patients with type 2 diabetes and high risk of CVD were randomised into four groups (n=20 in each) receiving either tablet placebo, empagliflozin, a combination of semaglutide and tablet placebo (herein referred to as the 'semaglutide' group), or the combination of semaglutide and empagliflozin (referred to as the 'combination-therapy' group).

The semaglutide and the combination-therapy group had semaglutide treatment for 16 weeks and then had either tablet placebo or empagliflozin added to the treatment, respectively, for a further 16 weeks; the placebo and empagliflozin groups were treated with the respective monotherapy for 32 weeks.

How the Study Was Run

In design terms this was a randomized and placebo-controlled 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 comparison arm used a placebo, so changes seen with Semaglutide could be set against what happens without it.

A time span of 16 weeks appears in the methods.

This was a substudy of a randomised clinical trial on the effects of semaglutide and empagliflozin alone or in combination.

The researchers analysed the effects of treatment on changes in ADC (cortical, medullary and the cortico-medullary difference [ΔADC; medullary ADC subtracted from cortical ADC]), as well as TKV measured by MRI.

What Was Measured

The subject headings attached to it are Glucosides, Benzhydryl Compounds, Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Kidney, Diffusion Magnetic Resonance Imaging and Sodium-Glucose Transporter 2 Inhibitors.

Author keywords: Apparent diffusion coefficient, Diffusion-weighted magnetic resonance imaging, Glucagon-like peptide-1 receptor agonist, Sodium–glucose cotransporter 2 inhibitors, Total kidney volume and Type 2 diabetes.

What This Means in Plain Language

The paper is a randomized and placebo-controlled study of Semaglutide over 16 weeks.

The abstract goes on to report its results in about 11 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2024 (Diabetologia), a journal based in Germany.

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