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DIALYSIS-TIR Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06042153
Recruitment Status : Recruiting
First Posted : September 18, 2023
Last Update Posted : February 13, 2024
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes End Stage Renal Disease on Dialysis Drug: Semaglutide Drug: Placebo Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled, trial comparing semaglutide subcutaneously weekly versus matched placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The randomization and each dispensation will be performed by blinded study staff using an electronic system coded with the randomization code, to ensure all study personnel remains blinded.
Primary Purpose: Treatment
Official Title: Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study
Actual Study Start Date : December 5, 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Arm 1 - Semaglutide
Participants will receive semaglutide as an adjunct to standard-of-care.
Drug: Semaglutide
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 Comparator: Arm 2- Placebo
Participants will receive placebo (semaglutide) as an adjunct to standard-of-care.
Drug: Placebo
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 Outcome Measures :
  1. Change in TIR (70-180 mg/dl) [ Time Frame: Baseline, 52 weeks ]
    Measured in percentage by Continuous glucose monitor (CGM)


Secondary Outcome Measures :
  1. Change in Time in high range (180-250 mg/dl) [ Time Frame: Baseline, 52 weeks ]
    Measured in percentage by Continuous glucose monitor (CGM)

  2. Change in Time in very high range (>250 mg/dl) [ Time Frame: Baseline, 52 weeks ]
    Measured in percentage by Continuous glucose monitor (CGM)

  3. Change in Time in low range (54-69 mg/dl) [ Time Frame: Baseline, 52 weeks ]
    Measured in percentage by Continuous glucose monitor (CGM)

  4. Change in Time in very low range (<54 mg/dl) [ Time Frame: Baseline, 52 weeks ]
    Measured in percentage by Continuous glucose monitor (CGM)

  5. Proportion of participants with TIR 70-180 mg/dl for 70% of the day [ Time Frame: 52 weeks ]
    Measured in percentage by CGM

  6. Proportion of participants with TIR 70-180 mg/dl with more than equal to 5% improvement from baseline [ Time Frame: 52 weeks ]
    Measured in percentage by CGM

  7. Proportion of participants with Time below range <70 mg/dL for <4% of each day [ Time Frame: 52 weeks ]
    Measured in percentage by CGM

  8. Proportion of participants with Time below range <54 mg/dL for <1% of each day [ Time Frame: 52 weeks ]
    Measured in percentage by CGM

  9. Proportion of participants with Time above range >180 mg/dL for <25% of each day [ Time Frame: 52 weeks ]
    Measured in percentage by CGM

  10. Change in haemoglobin A1c (HbA1c) [ Time Frame: Baseline, 52 weeks ]
    Measured in percentage

  11. Total daily dose of insulin [ Time Frame: 52 weeks ]
    Measured as units/day

  12. Number of oral glucose lowering agents [ Time Frame: 52 weeks ]
    Measured as count

  13. 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 ]
    Measured in percentage

  14. Proportion of participants with mean glucose <154 mg/dL and <1% time below range <54 mg/dL [ Time Frame: 52 weeks ]
    Measured in percentage

  15. Number of participants with Severe hypoglycemia [ Time Frame: 52 weeks ]
    Measured in count

  16. Change in body weight [ Time Frame: Baseline, 52 weeks ]
    Measured in kilograms

  17. Change in waist circumference [ Time Frame: Baseline, 52 weeks ]
    Measured in centimeters

  18. Change in percentage total body fat [ Time Frame: Baseline, 52 weeks ]
    Measured in percentage

  19. Change in percentage lean mass [ Time Frame: Baseline, 52 weeks ]
    Measured in percentage

  20. Change in Inter-dialysis weight gain [ Time Frame: Baseline, 52 weeks ]
    Measured in kilograms

  21. Number of participants hospitalized [ Time Frame: 52 weeks ]
    Measured in count

  22. Total number of days spent in hospital [ Time Frame: 52 weeks ]
    Measured in count

  23. Total score of Diabetes Treatment Satisfaction questionnaire [ Time Frame: 52 weeks ]
    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.

  24. Total score of EQ-5D-5L [ Time Frame: 52 weeks ]

    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


  25. Total score of Kidney disease QoL short form [ Time Frame: 52 weeks ]
    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.").



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06042153


Contacts
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Contact: Marielle Berger-Nagele, MS 214-648-2363 marielle.berger-nagele@utsouthwestern.edu
Contact: Ileana Cuevas, PhD 214-648-2321 ileana.cuevas@utsouthwestern.edu

Locations
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United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Alex Kass, MSN, MBA, RN    984-974-3009    alex_kass@med.unc.edu   
Contact: Klara Klein, MD    9849743004    klara_klein@med.unc.edu   
Principal Investigator: Klara Klein, MD         
United States, Texas
Davita UT Southwestern - Oak Cliff Recruiting
Dallas, Texas, United States, 75224
Contact: Marielle Berger-Nagele, MS       marielle.berger-nagele@utsouthwestern.edu   
Contact: Ileana Cuevas, PhD       ileana.cuevas@utsouthwestern.edu   
DaVita UT Southwestern - East Dallas Not yet recruiting
Dallas, Texas, United States, 75228
Contact: Marielle Berger-Nagele, MS    2146482363    marielle.berger-nagele@utsw.edu   
Contact: Ileana Cuevas, PhD    2146482321    ileana.cuevas@utsouthwestern.edu   
Principal Investigator: Ildiko Lingvay, MD, MPH, MSCS         
DaVita UT Southwestern - Preston Not yet recruiting
Dallas, Texas, United States, 75240
Contact: Marielle Berger-Nagele, MS    2146482363    marielle.berger-nagele@utsw.edu   
Contact: Ileana Cuevas, PhD    2146482321    ileana.cuevas@utsouthwestern.edu   
Principal Investigator: Ildiko Lingvay, MD, MPH, MSCS         
DaVita UT Southwestern - Irving Recruiting
Irving, Texas, United States, 75062
Contact: Marielle Berger-Nagele, MS       marielle.berger-nagele@utsouthwestern.edu   
Contact: Ileana Cuevas, PhD       ileana.cuevas@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Ildiko Lingvay, MD, MPH, MSCS UT Southwestern Medical Center
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Responsible Party: Ildiko Lingvay, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT06042153    
Other Study ID Numbers: STU-2022-0786
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: February 13, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes
Semaglutide
Glucagon-Like Peptide-1 Receptor Agonists
Hypoglycemic Agents
Physiological Effects of Drugs