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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
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

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of North Carolina
Coordinator of this site? Confirm its status
Chapel HillUnited StatesUnknown status
Davita UT Southwestern - Oak Cliff
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
DaVita UT Southwestern - Preston
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
DaVita UT Southwestern - East Dallas
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
DaVita UT Southwestern - Irving
Coordinator of this site? Confirm its status
IrvingUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.