Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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%

Locations
United States
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Texas
DaVita UT Southwestern - East Dallas
RECRUITING
Dallas
Davita UT Southwestern - Oak Cliff
RECRUITING
Dallas
DaVita UT Southwestern - Preston
RECRUITING
Dallas
DaVita UT Southwestern - Irving
RECRUITING
Irving
Contact Information
Primary
Marielle Berger-Nagele, MS
marielle.berger-nagele@utsouthwestern.edu
214-648-2363
Backup
Ileana Cuevas, PhD
ileana.cuevas@utsouthwestern.edu
214-648-2321
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2028-09
Participants
Target number of participants: 157
Treatments
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.
Sponsors
Leads: University of Texas Southwestern Medical Center
Collaborators: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov