Semaglutide Treatment for Hyperglycaemia After Renal Transplantation

What Was Tested

The trial (phase 4) is built around Semaglutide.

Background: Post-transplant hyperglycaemia occurs frequently in renal transplant recipients within the first two weeks after transplantation.

Standard-of-care is primarily based on insulin treatment with the adherent risk of hypoglycaemia and weight gain.

It had two arms (groups): Semaglutide treated group (active comparator) and Placebo treated group (placebo comparator).

Oral semaglutide once-daily as add-on to standard-of-care for post-transplant hyperglycaemia.

Oral placebo once-daily as add-on to standard-of-care for post-transplant hyperglycaemia.

The registry classes the interventions as drug.

More on the Plan

Introduction: In renal transplant recipients, hyperglycaemia develops frequently in the immediate period after renal transplantation.

Insulin is the primary choice of treatment but carries the adherent risk of hypoglycaemia and weight gain.

It also has the ability to delay progression of chronic kidney disease (CKD).

Background: Patients developing end-stage renal disease require renal replacement therapy by either haemodialysis, peritoneal dialysis, or renal transplantation.

Who Took Part

The registry lists 104 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Written informed consent obtained before any trial-related procedures are performed. Male or female; age: 18-80 years. Subject must be willing and able to comply with trial protocol.

The full record lists 5 inclusion and 18 exclusion criteria; among the exclusions: type 1 diabetes; high risk immunological transplantation (not including abo-incompatible or re-transplantation); chronic pancreatitis/previous acute pancreatitis.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

In this single-blind Semaglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2024-09-19 with completion listed for 2027-12.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean sensor glucose (mmol/L) (time frame: 14 weeks).

It also tracked 29 secondary outcomes, for example Glucose variability (standard deviation [mmol/L] and coefficient of variation [%]), Glucose management indicator (mmol/mol and %), HbA1c (mmol/mol), HbA1c (%), Body weight (kg) and Body mass index (kg/m2).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 104 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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