Renal Effects of Treatment With Empagliflozin Alone or in Combination With Semaglutide in Patients With Type 2 Diabetes and Albuminuria

What Was Tested

The trial (phase 4) is built around Semaglutide.

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

The registry classes the interventions as drug and other.

More on the Plan

Previous studies have mainly focused on glycaemic parameters when combining a GLP-1 agonist and SGLT2 inhibitor.

From a renal perspective, it is of major interest to investigate if a stepwise initiation of semaglutide or placebo added to ongoing empagliflozin therapy would complement or have an additive effect on renal parameters.

Who Took Part

Enrollment: 80 planned participants were the target.

It was open to people of any sex aged from 18 years up to 100 years.

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

Examples of who could join: Given written informed consent. Ability to communicate with the investigator and understand informed consent.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products; cardiac disease defined as: decompensated heart failure (nyha class iii-iv) and or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months; previous bowel resection.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-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.

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-11-01 with completion listed for 2021-07-01.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Albuminuria (time frame: From randomisation to week 52).

It also tracked 5 secondary outcomes, for example Hba1c, GFR, 24 hour blood pressure, Vasoactive hormones and Inflammatory and endothelial biomarkers.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 80 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.