NCT06042153Active, not recruitingPhase 4
DIALYSIS-TIR Study
Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 11 Sept 2023
- Start date
- 5 Dec 2023
- Primary completion date
- Sept 2027
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT06042153
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 43
- From 5 Dec 2023 to the primary completion date, Sept 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current participation in other interventional trials or last dose of any investigational product within 4 half- lives at the time of randomization
- Current diagnosis of gastroparesis or enteropathywhich in the opinion of investigator precludes safe treatment with GLP-1 RA.
Other illness
- Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia type 2
- Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, or related products)
- Any medical condition which in the judgement of the investigator precludes safe participation in the trial (includes, but not limited to active neoplasm, severe heart failure, recent cardiovascular event, severe frailty, planned cardiac or vascular surgeries on the day of screening etc)
- Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetes mellitus, MODY, LADA, drug induced, etc.)
- Hypoglycaemia unawareness, or history of frequent or severe hypoglycaemia (in the opinion of the investigator)
- Personal history of chronic pancreatitis, or acute pancreatitis within 180 days of screening
Other
- BMI \< 23 kg/m2 at screening
- Current (within the past 90 days of screening) use of any GLP-1 RA
- Pregnant, breast-feeding or the intention of becoming pregnant, or not using effective contraceptive measures
- Active weight loss, defined as weight loss of \>5% of body weight in the past 3 months
- If weight loss is not desired by the participant, or if the provider or investigator considers intentional weight loss to be detrimental to the health of the participant
- Known current uncontrolled or unstable retinopathy (by medical history)
Who the study is looking for
- Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedures that are carried out as a part of trial, including activities to determine suitability for the trial.
- 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
- Current treatment with any glucose lowering pharmacotherapy, at a stable dose for at least 30 days. DPP-4 Inhibitors will be allowed at study entry and will be stopped at randomization.
- Minimum of 80% valid data on the 10-day Continuous Glucose Monitor download
- Time in Range 15 to 60%
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Davita UT Southwestern - Oak Cliff Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| DaVita UT Southwestern - Preston Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| DaVita UT Southwestern - East Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| DaVita UT Southwestern - Irving Coordinator of this site? Confirm its status | Irving | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.