Clinical trial NCT06042153: DIALYSIS-TIR Study
Official title: Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type 2 Diabetes
End Stage Renal Disease on Dialysis
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2023-09-18
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled, trial comparing semaglutide subcutaneously weekly versus matched placebo
Primary purpose: TREATMENT

Brief 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.

Detailed description: The researchers also have a Data Safety Monitoring Plan in place.

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)

Primary outcomes:
measure: Change in TIR (70-180 mg/dl)
timeFrame: Baseline, 52 weeks
Secondary outcomes:
measure: Change in Time in high range (180-250 mg/dl)
timeFrame: Baseline, 52 weeks
measure: Change in Time in very high range (>250 mg/dl)
timeFrame: Baseline, 52 weeks
measure: Change in Time in low range (54-69 mg/dl)
timeFrame: Baseline, 52 weeks
measure: Change in Time in very low range (<54 mg/dl)
timeFrame: Baseline, 52 weeks
measure: Proportion of participants with TIR 70-180 mg/dl for 70% of the day
timeFrame: 52 weeks
measure: Proportion of participants with TIR 70-180 mg/dl with more than equal to 5% improvement from baseline
timeFrame: 52 weeks
measure: Proportion of participants with Time below range <70 mg/dL for <4% of each day
timeFrame: 52 weeks
measure: Proportion of participants with Time below range <54 mg/dL for <1% of each day
timeFrame: 52 weeks
measure: Proportion of participants with Time above range >180 mg/dL for <25% of each day
timeFrame: 52 weeks
measure: Change in haemoglobin A1c (HbA1c)
timeFrame: Baseline, 52 weeks
measure: Total daily dose of insulin
timeFrame: 52 weeks
measure: Number of oral glucose lowering agents
timeFrame: 52 weeks
measure: Proportion of participants with >10 points improvement in % TIR 70-180 mg/dL without an increase in time below range <54 mg/dL of >0.5%
timeFrame: 52 weeks
measure: Proportion of participants with mean glucose <154 mg/dL and <1% time below range <54 mg/dL
timeFrame: 52 weeks
measure: Number of participants with Severe hypoglycemia
timeFrame: 52 weeks
measure: Change in body weight
timeFrame: Baseline, 52 weeks
measure: Change in waist circumference
timeFrame: Baseline, 52 weeks
measure: Change in percentage total body fat
timeFrame: Baseline, 52 weeks
measure: Change in percentage lean mass
timeFrame: Baseline, 52 weeks
measure: Change in Inter-dialysis weight gain
timeFrame: Baseline, 52 weeks
measure: Number of participants hospitalized
timeFrame: 52 weeks
measure: Total number of days spent in hospital
timeFrame: 52 weeks
measure: Total score of Diabetes Treatment Satisfaction questionnaire
timeFrame: 52 weeks
measure: Total score of EQ-5D-5L
timeFrame: 52 weeks
measure: Total score of Kidney disease QoL short form
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Dallas
country: United States
facility: Davita UT Southwestern - Oak Cliff
state: Texas
city: Dallas
country: United States
facility: DaVita UT Southwestern - East Dallas
state: Texas
city: Dallas
country: United States
facility: DaVita UT Southwestern - Preston
state: Texas
city: Irving
country: United States
facility: DaVita UT Southwestern - Irving
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Ildiko Lingvay, MD, MPH, MSCS
role: PRINCIPAL_INVESTIGATOR
References: