DIALYSIS-TIR Study

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Sep 11, 2023

Keywords

ClinConnect Summary

The DIALYSIS-TIR Study is a clinical trial that aims to understand how well a medication called semaglutide can help control blood sugar levels in people with type 2 diabetes who are on dialysis. In this study, some participants will receive semaglutide while others will receive a placebo, which is a "dummy" medication that looks like the real treatment but has no active ingredients. Participants will be randomly assigned to either group. The study will last for a little over a year, and participants will need to inject the medication once a week. They will also wear a device that continuously measures their blood sugar levels for 10 days at different times throughout the study.

To participate, individuals must be adults over 18 years old, have been diagnosed with type 2 diabetes for at least six months, and have been on dialysis for six months or more. They should also be on stable diabetes medication. However, there are certain criteria that could exclude someone from participating, such as having a specific weight range, recent weight loss, or certain medical conditions. This study is currently recruiting participants, and it offers a chance to contribute to research that could improve diabetes management for those on dialysis.

Gender

ALL

Eligibility 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)