DIALYSIS-TIR Study

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide.

This study will look at control of blood sugar levels in persons with type 2 diabetes mellitus currently on chronic dialysis.

Researchers will compare blood sugar levels in people taking semaglutide to people taking "dummy" medicine.

The treatment participants get will be decided randomly.

It had two arms (groups): Arm 1 - Semaglutide (experimental) and Arm 2- Placebo (placebo comparator).

Participants will receive semaglutide as an adjunct to standard-of-care.

Participants will receive placebo (semaglutide) as an adjunct to standard-of-care.

The registry classes the interventions as drug.

More on the Plan

The researchers also have a Data Safety Monitoring Plan in place.

Who Took Part

The registry lists 43 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: Male or female Adults (age \> 18 years at the time of signing the consent). Type 2 diabetes mellitus diagnosed \> 6 months prior to screening. On current chronic treatment with Hemodialysis or Peritoneal dialysis for \> 6 months prior to screening.

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: BMI \< 23 kg/m2 at screening; current (within the past 90 days of screening) use of any glp-1 ra; personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2023-12-05 with completion listed for 2027-09.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in TIR ([amount hidden]/dl).

It also tracked 25 secondary outcomes, for example Change in haemoglobin A1c (HbA1c), Number of oral glucose lowering agents, Number of participants with Severe hypoglycemia, Change in body weight, Change in waist circumference and Change in percentage total body fat.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 43 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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