Clinical trial

DIALYSIS-TIR Study

Active, not recruiting ยท Phase 4 ยท 1 countries ยท Registry ID NCT06042153

Active, not recruitingPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes, End Stage Renal Disease on Dialysis

Full registry 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)

Treatments and study arms

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.

Primary outcomes

Change in TIR (70-180 mg/dl)Baseline, 52 weeks

Measured in percentage by Continuous glucose monitor (CGM)

Study locations

5 locations were listed when this page was built. The first 40 are shown.

University of North Carolina๐Ÿ‡บ๐Ÿ‡ธ Chapel Hill, North Carolina, United States
DaVita UT Southwestern - East Dallas๐Ÿ‡บ๐Ÿ‡ธ Dallas, Texas, United States
DaVita UT Southwestern - Preston๐Ÿ‡บ๐Ÿ‡ธ Dallas, Texas, United States
Davita UT Southwestern - Oak Cliff๐Ÿ‡บ๐Ÿ‡ธ Dallas, Texas, United States
DaVita UT Southwestern - Irving๐Ÿ‡บ๐Ÿ‡ธ Irving, Texas, United States