DIALYSIS-TIR Study
NCT06042153 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2026-01-13
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.
Conditions
- Type 2 Diabetes
- End Stage Renal Disease on Dialysis
Interventions
- DRUG
-
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 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.
Sponsors & Collaborators
-
University of North Carolina, Chapel Hill
collaborator OTHER -
University of Texas Southwestern Medical Center
lead OTHER
Principal Investigators
-
Ildiko Lingvay, MD, MPH, MSCS · University of Texas Southwestern Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-05
- Primary Completion
- 2027-09-30
- Completion
- 2028-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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