Examining blood sugar control in diabetes patients on dialysis
Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study
PHASE4 · University of Texas Southwestern Medical Center · NCT06042153
This study is testing if a medication called semaglutide can help adults with type 2 diabetes who are on dialysis better control their blood sugar levels.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 157 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 5 sites (Chapel Hill, North Carolina and 4 other locations) |
| Trial ID | NCT06042153 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of semaglutide in controlling blood sugar levels in adults with type 2 diabetes who are undergoing chronic dialysis. Participants will be randomly assigned to receive either semaglutide or a placebo, with weekly injections over a duration of 13 months. Throughout the study, participants will wear a continuous glucose monitor to track their blood sugar levels at various intervals. The research includes a Data Safety Monitoring Plan to ensure participant safety.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with type 2 diabetes on chronic dialysis for at least six months.
Not a fit: Patients with a BMI below 23 kg/m2 or those currently using GLP-1 receptor agonists may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood sugar management for patients with type 2 diabetes on dialysis.
How similar studies have performed: Other studies have shown promise in using GLP-1 receptor agonists for diabetes management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 months prior to screening 5. 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. 6. Minimum of 80% valid data on the 10-day Continuous Glucose Monitor download 7. Time in Range 15 to 60% 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 Endocrine Neoplasia type 2 4. Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, or related products) 5. Pregnant, breast-feeding or the intention of becoming pregnant, or not using effective contraceptive measures 6. Active weight loss, defined as weight loss of \>5% of body weight in the past 3 months 7. Current participation in other interventional trials or last dose of any investigational product within 4 half- lives at the time of randomization 8. 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) 9. 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 10. Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetes mellitus, MODY, LADA, drug induced, etc.) 11. Current diagnosis of gastroparesis or enteropathywhich in the opinion of investigator precludes safe treatment with GLP-1 RA. 12. Hypoglycaemia unawareness, or history of frequent or severe hypoglycaemia (in the opinion of the investigator) 13. Personal history of chronic pancreatitis, or acute pancreatitis within 180 days of screening 14. Known current uncontrolled or unstable retinopathy (by medical history)
Where this trial is running
Chapel Hill, North Carolina and 4 other locations
- University of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)
- Davita UT Southwestern - Oak Cliff — Dallas, Texas, United States (RECRUITING)
- DaVita UT Southwestern - East Dallas — Dallas, Texas, United States (RECRUITING)
- DaVita UT Southwestern - Preston — Dallas, Texas, United States (RECRUITING)
- DaVita UT Southwestern - Irving — Irving, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Ildiko Lingvay, MD, MPH, MSCS — UT Southwestern Medical Center
- Study coordinator: Marielle Berger-Nagele, MS
- Email: marielle.berger-nagele@utsouthwestern.edu
- Phone: 214-648-2363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, End Stage Renal Disease on Dialysis