NCT06042153

DIALYSIS-TIR Study

Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. Participants will need to inject the study medication once a week. The study will last for 1 year and a month. Participants will be asked to wear a sensor that measures blood sugar levels for a period of 10 days at five different time points during the study.

Detailed description

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

Conditions

• Type 2 Diabetes
• End Stage Renal Disease on Dialysis

Interventions

Type	Name	Description
DRUG	Semaglutide	Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.25 mg; dose will gradually be increased every 4 weeks up to 1.0 mg.
DRUG	Placebo	Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.

Timeline

• Start date: 2023-12-05
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2023-09-18
• Last updated: 2026-01-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study