Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation

What Was Tested

The trial (phase 2) is built around Exenatide.

It had two arms (groups): Exenatide SR Intervention Group (experimental) and Standard of Care (no intervention).

The registry classes the interventions as drug.

More on the Plan

New diabetes can develop after transplant and may affect a transplanted kidney's health and a recipient's overall health.

Currently, patients who are pre-diabetic are encouraged to exercise and lose weight.

Exenatide SR is medication given by weekly injection.

This medicine is already in use and approved by the US Food and Drug Administration (FDA) in patients with diabetes.

Who Took Part

9 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: Recipients of solitary kidney transplants (i.e. not combined liver-kidney, pancreas-kidney etc.).

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: diabetes pre-transplantation; diabetes at 4 months; \<18 years of age.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Being open-label, the Exenatide study did not mask who received what.

It started in 2019-05-09 with completion listed for 2021-10-18.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression From Prediabetes to Diabetes (time frame: 12 months after transplantation).

It also tracked 7 secondary outcomes, for example Progression From Prediabetes to Diabetes, Creatinine, Hemoglobin A1c, Incidence of Mesangial Expansion, Graft Loss and Adverse Events for Exenatide SR Intervention.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 9 people.

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

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

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