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DIALYSIS-TIR Study
Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
5
Recruiting sites
—
Enrollment
43
actual
Study population
Chronic kidney disease, Type 2 diabetes
Key I/E criterion
—
Primary endpoint
•CGM time-in-range
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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)
Endpoints (26)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Cardiovascular outcomes
2 endpointsNumber of participants hospitalized
Time frame:52 weeks
All-cause hospitalization
event count, event
Total number of days spent in hospital
Time frame:52 weeks
event count, event
Weight & body composition
5 endpointsChange in body weight
Time frame:Baseline, 52 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Change in waist circumference
Time frame:Baseline, 52 weeks
Waist circumference, change
change from baseline, improvement
Change in percentage total body fat
Time frame:Baseline, 52 weeks
Total fat mass
change from baseline, improvement
Change in percentage lean mass
Time frame:Baseline, 52 weeks
Lean mass
change from baseline, improvement
Change in Inter-dialysis weight gain
Time frame:Baseline, 52 weeks
change from baseline, improvement
Glycemic / diabetes
15 endpointsChange in TIR (70-180 mg/dl)
Time frame:Baseline, 52 weeks
CGM time-in-range
change from baseline, improvement
Change in Time in high range (180-250 mg/dl)
Time frame:Baseline, 52 weeks
CGM time-above-range
change from baseline, improvement
Change in Time in very high range (>250 mg/dl)
Time frame:Baseline, 52 weeks
CGM time-above-range
change from baseline, improvement
Change in Time in low range (54-69 mg/dl)
Time frame:Baseline, 52 weeks
CGM time-below-range
change from baseline, improvement
Change in Time in very low range (<54 mg/dl)
Time frame:Baseline, 52 weeks
CGM time-below-range
change from baseline, improvement
Proportion of participants with TIR 70-180 mg/dl for 70% of the day
Time frame:52 weeks
CGM time-in-range
threshold achievement, improvement
Proportion of participants with TIR 70-180 mg/dl with more than equal to 5% improvement from baseline
Time frame:52 weeks
CGM time-in-range
threshold achievement, improvement
Proportion of participants with Time below range <70 mg/dL for <4% of each day
Time frame:52 weeks
CGM time-below-range
threshold achievement, improvement
Proportion of participants with Time below range <54 mg/dL for <1% of each day
Time frame:52 weeks
CGM time-below-range
threshold achievement, improvement
Proportion of participants with Time above range >180 mg/dL for <25% of each day
Time frame:52 weeks
CGM time-above-range
threshold achievement, improvement
Change in haemoglobin A1c (HbA1c)
Time frame:Baseline, 52 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Total daily dose of insulin
Time frame:52 weeks
descriptive
Number of oral glucose lowering agents
Time frame:52 weeks
descriptive
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%
Time frame:52 weeks
CGM time-in-range
threshold achievement, improvement
Proportion of participants with mean glucose <154 mg/dL and <1% time below range <54 mg/dL
Time frame:52 weeks
threshold achievement, improvement
componentsmean glucose threshold 154 mgdl, cgm time below range threshold 54mgdl lt1pct
Patient-reported / QoL
3 endpointsTotal score of Diabetes Treatment Satisfaction questionnaire
Time frame:52 weeks
descriptive, improvement
Total score of EQ-5D-5L
Time frame:52 weeks
EQ-5D index
descriptive, improvement
Total score of Kidney disease QoL short form
Time frame:52 weeks
descriptive, improvement
Safety / tolerability / PK
1 endpointNumber of participants with Severe hypoglycemia
Time frame:52 weeks
Severe hypoglycemia
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.