DIALYSIS-TIR Study

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06042153
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — 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.
  • Placebo — 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.

Study Details

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.

Key Dates

Start date
Dec 5, 2023
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
43 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 - Semaglutide
    Participants will receive semaglutide as an adjunct to standard-of-care.
  • Placebo Comparator: Arm 2- Placebo
    Participants will receive placebo (semaglutide) as an adjunct to standard-of-care.

Primary Outcome Measure

Change in TIR (70-180 mg/dl) [ Time Frame: Baseline, 52 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27599-
DaVita UT Southwestern - East DallasDallasTexas75228-
Davita UT Southwestern - Oak CliffDallasTexas75224-
DaVita UT Southwestern - PrestonDallasTexas75240-
DaVita UT Southwestern - IrvingIrvingTexas75062-

Find similar trials in Chapel Hill, NC

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of North Carolina· Chapel Hill, NCDaVita UT Southwestern - East Dallas· Dallas, TXDavita UT Southwestern - Oak Cliff· Dallas, TXDaVita UT Southwestern - Preston· Dallas, TXDaVita UT Southwestern - Irving· Irving, TX

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