DIALYSIS-TIR Study

Last updated: January 9, 2026
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Active - Not Recruiting

Phase

4

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Diabetes Mellitus Types I And Ii

Treatment

Placebo

Semaglutide

Clinical Study ID

NCT06042153
STU-2022-0786
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.

  2. Male or female Adults (age > 18 years at the time of signing the consent)

  3. Type 2 diabetes mellitus diagnosed > 6 months prior to screening

  4. On current chronic treatment with Hemodialysis or Peritoneal dialysis for > 6 monthsprior to screening

  5. Current treatment with any glucose lowering pharmacotherapy, at a stable dose for atleast 30 days. DPP-4 Inhibitors will be allowed at study entry and will be stoppedat randomization.

  6. Minimum of 80% valid data on the 10-day Continuous Glucose Monitor download

  7. Time in Range 15 to 60%

Exclusion

Exclusion Criteria:

  1. BMI < 23 kg/m2 at screening

  2. Current (within the past 90 days of screening) use of any GLP-1 RA

  3. Personal or family history of medullary thyroid cancer or Multiple EndocrineNeoplasia type 2

  4. Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, orrelated products)

  5. Pregnant, breast-feeding or the intention of becoming pregnant, or not usingeffective contraceptive measures

  6. Active weight loss, defined as weight loss of >5% of body weight in the past 3months

  7. Current participation in other interventional trials or last dose of anyinvestigational product within 4 half- lives at the time of randomization

  8. Any medical condition which in the judgement of the investigator precludes safeparticipation in the trial (includes, but not limited to active neoplasm, severeheart failure, recent cardiovascular event, severe frailty, planned cardiac orvascular surgeries on the day of screening etc)

  9. If weight loss is not desired by the participant, or if the provider or investigatorconsiders intentional weight loss to be detrimental to the health of the participant

  10. Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetesmellitus, MODY, LADA, drug induced, etc.)

  11. Current diagnosis of gastroparesis or enteropathywhich in the opinion ofinvestigator precludes safe treatment with GLP-1 RA.

  12. Hypoglycaemia unawareness, or history of frequent or severe hypoglycaemia (in theopinion of the investigator)

  13. Personal history of chronic pancreatitis, or acute pancreatitis within 180 days ofscreening

  14. Known current uncontrolled or unstable retinopathy (by medical history)

Study Design

Total Participants: 43
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
December 05, 2023
Estimated Completion Date:
September 30, 2028

Study Description

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

Connect with a study center

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • DaVita UT Southwestern - East Dallas

    Dallas, Texas 75228
    United States

    Active - Recruiting

  • DaVita UT Southwestern - Preston

    Dallas, Texas 75240
    United States

    Site Not Available

  • Davita UT Southwestern - Oak Cliff

    Dallas, Texas 75224
    United States

    Active - Recruiting

  • DaVita UT Southwestern - Irving

    Irving, Texas 75062
    United States

    Site Not Available

  • DaVita UT Southwestern - East Dallas

    Dallas 4684888, Texas 4736286 75228
    United States

    Site Not Available

  • DaVita UT Southwestern - Preston

    Dallas 4684888, Texas 4736286 75240
    United States

    Site Not Available

  • Davita UT Southwestern - Oak Cliff

    Dallas 4684888, Texas 4736286 75224
    United States

    Site Not Available

  • DaVita UT Southwestern - Irving

    Irving 4700168, Texas 4736286 75062
    United States

    Site Not Available

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