A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease

What Was Tested

This registered phase 3 trial tested Semaglutide.

The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes.

Participants will get semaglutide (active medicine) or placebo ('dummy medicine').

This is known as participants' study medicine - which treatment participants get is decided by chance.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

Participants are to receive semglutide for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.

Participants are to receive placebo (semglutide) for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.

The registry classes the interventions as drug.

Who Took Part

The registry lists 3533 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Diagnosed with type 2 diabetes mellitus. Renal impairment defined either by:.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations; use of any glucagon-like peptide-1 (glp-1) receptor agonist within 30 days prior to screening; myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening.

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.

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, investigator and outcomes assessor.

It started in 2019-06-17 with completion listed for 2024-01-09.

It ran at 413 sites in United States (117), Canada (32), Japan (27), Russia (21), India (17) and France (14).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 21 secondary outcomes, for example Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope), Number of Participants From Time of Randomization to Occurrence of Initiation of Chronic Renal Replacement Therapy, Annual Rate of Change in eGFR (Chronic Kidney Disease CKD-EPI) (Chronic eGFR Slope), Change From Baseline in eGFR (CKD-EPI) at Week 12, Change From Baseline in eGFR (Cystatin C CKD-EPI) at Week 104 and Change From Baseline in Urinary Albumin-to-creatinine Ratio (UACR) at Week 104: Ratio to Baseline.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 3533 people.

With 3533 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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