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Active not recruitingPhase 4

DIALYSIS-TIR Study

Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study

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

NCT IDNCT06042153
Org study IDSTU-2022-0786

Timeline

Milestones

Study first posted2023-09-18actual
Study start2023-12-05actual
Last update posted2026-01-13actual
Primary completion2027-09estimated (month precision)
Study completion2028-09estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Glycemic / diabetes
15
Weight & body composition
5
Patient-reported / QoL
3
Cardiovascular outcomes
2
Safety / tolerability / PK
1

Cardiovascular outcomes

2 endpoints
Secondary/protocol endpoint

Number of participants hospitalized

Time frame:52 weeks

All-cause hospitalization

event count, event

Secondary/protocol endpoint/low confidence

Total number of days spent in hospital

Time frame:52 weeks

event count, event

Weight & body composition

5 endpoints
Secondary/protocol endpoint

Change in body weight

Time frame:Baseline, 52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:Baseline, 52 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in percentage total body fat

Time frame:Baseline, 52 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change in percentage lean mass

Time frame:Baseline, 52 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change in Inter-dialysis weight gain

Time frame:Baseline, 52 weeks

change from baseline, improvement

Glycemic / diabetes

15 endpoints
Primary/protocol endpoint

Change in TIR (70-180 mg/dl)

Time frame:Baseline, 52 weeks

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

Change in Time in high range (180-250 mg/dl)

Time frame:Baseline, 52 weeks

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

Change in Time in very high range (>250 mg/dl)

Time frame:Baseline, 52 weeks

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

Change in Time in low range (54-69 mg/dl)

Time frame:Baseline, 52 weeks

CGM time-below-range

change from baseline, improvement

Secondary/protocol endpoint

Change in Time in very low range (<54 mg/dl)

Time frame:Baseline, 52 weeks

CGM time-below-range

change from baseline, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Change in haemoglobin A1c (HbA1c)

Time frame:Baseline, 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Total daily dose of insulin

Time frame:52 weeks

descriptive

Secondary/protocol endpoint

Number of oral glucose lowering agents

Time frame:52 weeks

descriptive

Secondary/protocol endpoint

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

Secondary/protocol endpoint/low confidence

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 endpoints
Secondary/protocol endpoint

Total score of Diabetes Treatment Satisfaction questionnaire

Time frame:52 weeks

descriptive, improvement

Secondary/protocol endpoint

Total score of EQ-5D-5L

Time frame:52 weeks

EQ-5D index

descriptive, improvement

Secondary/protocol endpoint

Total score of Kidney disease QoL short form

Time frame:52 weeks

descriptive, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of participants with Severe hypoglycemia

Time frame:52 weeks

Severe hypoglycemia

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.