Examining blood sugar control in diabetes patients on dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.