Type 2 DiabetesPhase 4NCT06042153
DIALYSIS-TIR Study
A Phase 4 study testing Semaglutide in people with Type 2 Diabetes and End Stage Renal Disease on Dialysis, run by University of Texas Southwestern Medical Center at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, End Stage Renal Disease on Dialysis
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Dec 2023to Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Male or female Adults (age > 18 years at the time of signing the consent)
- Type 2 diabetes mellitus diagnosed > 6 months prior to screening
- On current chronic treatment with Hemodialysis or Peritoneal dialysis for > 6 months prior to screening
- 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.
- Minimum of 80% valid data on the 10-day Continuous Glucose Monitor download
- Time in Range 15 to 60%
Who cannot join
- BMI < 23 kg/m2 at screening
- Current (within the past 90 days of screening) use of any GLP-1 RA
- Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia type 2
- Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, or related products)
- Pregnant, breast-feeding or the intention of becoming pregnant, or not using effective contraceptive measures
- Active weight loss, defined as weight loss of >5% of body weight in the past 3 months
Show all 14Show fewer
- Current participation in other interventional trials or last dose of any investigational product within 4 half- lives at the time of randomization
- 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)
- 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
- Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetes mellitus, MODY, LADA, drug induced, etc.)
- Current diagnosis of gastroparesis or enteropathywhich in the opinion of investigator precludes safe treatment with GLP-1 RA.
- Hypoglycaemia unawareness, or history of frequent or severe hypoglycaemia (in the opinion of the investigator)
- Personal history of chronic pancreatitis, or acute pancreatitis within 180 days of screening
- Known current uncontrolled or unstable retinopathy (by medical history)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
Davita UT Southwestern - Oak Cliff
Dallas, Texas, 75224
DaVita UT Southwestern - East Dallas
Dallas, Texas, 75228
DaVita UT Southwestern - Preston
Dallas, Texas, 75240
DaVita UT Southwestern - Irving
Irving, Texas, 75062
About this study
Official title: Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study
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.
Read the detailed description
The researchers also have a Data Safety Monitoring Plan in place.
- Being tested
- Semaglutide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Semaglutide | Experimental | Participants will receive semaglutide as an adjunct to standard-of-care. Receives: Drug: Semaglutide |
| Arm 2- Placebo | Placebo comparator | Participants will receive placebo (semaglutide) as an adjunct to standard-of-care. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TIR (70-180 mg/dl)
Measured in percentage by Continuous glucose monitor (CGM)
Measured: Baseline, 52 weeks
Secondary outcomes (25)
Change in Time in high range (180-250 mg/dl)
Measured in percentage by Continuous glucose monitor (CGM)
Measured: Baseline, 52 weeks
Change in Time in very high range (>250 mg/dl)
Measured in percentage by Continuous glucose monitor (CGM)
Measured: Baseline, 52 weeks
Change in Time in low range (54-69 mg/dl)
Measured in percentage by Continuous glucose monitor (CGM)
Measured: Baseline, 52 weeks
Change in Time in very low range (<54 mg/dl)
Measured in percentage by Continuous glucose monitor (CGM)
Measured: Baseline, 52 weeks
Proportion of participants with TIR 70-180 mg/dl for 70% of the day
Measured in percentage by CGM
Measured: 52 weeks
Proportion of participants with TIR 70-180 mg/dl with more than equal to 5% improvement from baseline
Measured in percentage by CGM
Measured: 52 weeks
Proportion of participants with Time below range <70 mg/dL for <4% of each day
Measured in percentage by CGM
Measured: 52 weeks
Proportion of participants with Time below range <54 mg/dL for <1% of each day
Measured in percentage by CGM
Measured: 52 weeks
Proportion of participants with Time above range >180 mg/dL for <25% of each day
Measured in percentage by CGM
Measured: 52 weeks
Change in haemoglobin A1c (HbA1c)
Measured in percentage
Measured: Baseline, 52 weeks
Total daily dose of insulin
Measured as units/day
Measured: 52 weeks
Number of oral glucose lowering agents
Measured as count
Measured: 52 weeks
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%
Measured in percentage
Measured: 52 weeks
Proportion of participants with mean glucose <154 mg/dL and <1% time below range <54 mg/dL
Measured in percentage
Measured: 52 weeks
Number of participants with Severe hypoglycemia
Measured in count
Measured: 52 weeks
Change in body weight
Measured in kilograms
Measured: Baseline, 52 weeks
Change in waist circumference
Measured in centimeters
Measured: Baseline, 52 weeks
Change in percentage total body fat
Measured in percentage
Measured: Baseline, 52 weeks
Change in percentage lean mass
Measured in percentage
Measured: Baseline, 52 weeks
Change in Inter-dialysis weight gain
Measured in kilograms
Measured: Baseline, 52 weeks
Number of participants hospitalized
Measured in count
Measured: 52 weeks
Total number of days spent in hospital
Measured in count
Measured: 52 weeks
Total score of Diabetes Treatment Satisfaction questionnaire
Patient reported outcomes is assessed by Diabetes Treatment Satisfaction Score questionnaire which assesses patient satisfaction with diabetes treatment. It is composed of eight questions, each of which is scored by patients on a scale ranging from zero (e.g., "very dissatisfied", "very inconvenient") to six (e.g., "very satisfied", "very convenient"). Treatment satisfaction is assessed as the sum of the scores of the six questions on the first factor, with a higher score indicating higher treatment satisfaction.
Measured: 52 weeks
Total score of EQ-5D-5L
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Possible scores range from 0-100, where higher score indicate better outcome
Measured: 52 weeks
Total score of Kidney disease QoL short form
The KDQOL-SF is a self-report measure developed for individuals with kidney disease and those on dialysis. It is a shorter version of a measure developed by the same authors. It includes 43 kidney disease-targeted items, such as the effects of the disease of activities of daily living, work status, and social interaction, and 36 items that provide a measure of physical and mental health, and 1 overall health rating item ranging from 0 ("worst possible health") to 10 ("best possible health.").
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start5 Dec 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled, trial comparing semaglutide subcutaneously weekly versus matched placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Ildiko Lingvay, University of Texas Southwestern Medical Center
- Investigators
- Ildiko Lingvay, MD, MPH, MSCS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042153
- Sponsor's protocol ID
- STU-2022-0786
- Status last verified
- Jan 2026
- First submitted
- 11 Sep 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study
- ClinicalTrials.gov ID
- NCT06042153
- Acronym / sponsor ID
- STU-2022-0786
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled, trial comparing semaglutide subcutaneously weekly versus matched placebo
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Semaglutide | Experimental | Drug: SemaglutideParticipants will receive semaglutide as an adjunct to standard-of-care. |
| Arm 2- Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo (semaglutide) as an adjunct to standard-of-care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Male or female Adults (age > 18 years at the time of signing the consent)
- Type 2 diabetes mellitus diagnosed > 6 months prior to screening
- On current chronic treatment with Hemodialysis or Peritoneal dialysis for > 6 months prior to screening
- 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.
Key exclusion criteria (14 listed)
- BMI < 23 kg/m2 at screening
- Current (within the past 90 days of screening) use of any GLP-1 RA
- Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia type 2
- Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, or related products)
- Pregnant, breast-feeding or the intention of becoming pregnant, or not using effective contraceptive measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideSemaglutide 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. | Drug | Arm 1 - Semaglutide |
| PlaceboPlacebo 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. | Drug | Arm 2- Placebo |
Primary outcome
Change in TIR (70-180 mg/dl)
Time frame: Baseline, 52 weeks
Measured in percentage by Continuous glucose monitor (CGM)
25 secondary outcomes
Change in Time in high range (180-250 mg/dl)
Time frame: Baseline, 52 weeks
Change in Time in very high range (>250 mg/dl)
Time frame: Baseline, 52 weeks
Change in Time in low range (54-69 mg/dl)
Time frame: Baseline, 52 weeks
Change in Time in very low range (<54 mg/dl)
Time frame: Baseline, 52 weeks
Proportion of participants with TIR 70-180 mg/dl for 70% of the day
Time frame: 52 weeks
Proportion of participants with TIR 70-180 mg/dl with more than equal to 5% improvement from baseline
Time frame: 52 weeks
Proportion of participants with Time below range <70 mg/dL for <4% of each day
Time frame: 52 weeks
Proportion of participants with Time below range <54 mg/dL for <1% of each day
Time frame: 52 weeks
Proportion of participants with Time above range >180 mg/dL for <25% of each day
Time frame: 52 weeks
Change in haemoglobin A1c (HbA1c)
Time frame: Baseline, 52 weeks
Total daily dose of insulin
Time frame: 52 weeks
Number of oral glucose lowering agents
Time frame: 52 weeks
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
Proportion of participants with mean glucose <154 mg/dL and <1% time below range <54 mg/dL
Time frame: 52 weeks
Number of participants with Severe hypoglycemia
Time frame: 52 weeks
Change in body weight
Time frame: Baseline, 52 weeks
Change in waist circumference
Time frame: Baseline, 52 weeks
Change in percentage total body fat
Time frame: Baseline, 52 weeks
Change in percentage lean mass
Time frame: Baseline, 52 weeks
Change in Inter-dialysis weight gain
Time frame: Baseline, 52 weeks
Number of participants hospitalized
Time frame: 52 weeks
Total number of days spent in hospital
Time frame: 52 weeks
Total score of Diabetes Treatment Satisfaction questionnaire
Time frame: 52 weeks
Total score of EQ-5D-5L
Time frame: 52 weeks
Total score of Kidney disease QoL short form
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ildiko Lingvay, MD, MPH, MSCS principal investigator
University of Texas Southwestern Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide in people with Type 2 Diabetes and End Stage Renal Disease on Dialysis, run by University of Texas Southwestern Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TIR (70-180 mg/dl) (time frame: Baseline, 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.