DIALYSIS-TIR Study

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06042153
• Other study ID #: STU-2022-0786
• Status: Recruiting
• Phase: Phase 4
• Start date: December 5, 2023
• Est. completion date: September 2026

Study information

• Verified date: February 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Marielle Berger-Nagele, MS
• Phone: 214-648-2363
• Email: marielle.berger-nagele[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 157
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic
• Type 2 Diabetes

Intervention

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
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.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	DaVita UT Southwestern - East Dallas	Dallas	Texas
United States	Davita UT Southwestern - Oak Cliff	Dallas	Texas
United States	DaVita UT Southwestern - Preston	Dallas	Texas
United States	DaVita UT Southwestern - Irving	Irving	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TIR (70-180 mg/dl)	Measured in percentage by Continuous glucose monitor (CGM)	Baseline, 52 weeks
Secondary	Change in Time in high range (180-250 mg/dl)	Measured in percentage by Continuous glucose monitor (CGM)	Baseline, 52 weeks
Secondary	Change in Time in very high range (>250 mg/dl)	Measured in percentage by Continuous glucose monitor (CGM)	Baseline, 52 weeks
Secondary	Change in Time in low range (54-69 mg/dl)	Measured in percentage by Continuous glucose monitor (CGM)	Baseline, 52 weeks
Secondary	Change in Time in very low range (<54 mg/dl)	Measured in percentage by Continuous glucose monitor (CGM)	Baseline, 52 weeks
Secondary	Proportion of participants with TIR 70-180 mg/dl for 70% of the day	Measured in percentage by CGM	52 weeks
Secondary	Proportion of participants with TIR 70-180 mg/dl with more than equal to 5% improvement from baseline	Measured in percentage by CGM	52 weeks
Secondary	Proportion of participants with Time below range <70 mg/dL for <4% of each day	Measured in percentage by CGM	52 weeks
Secondary	Proportion of participants with Time below range <54 mg/dL for <1% of each day	Measured in percentage by CGM	52 weeks
Secondary	Proportion of participants with Time above range >180 mg/dL for <25% of each day	Measured in percentage by CGM	52 weeks
Secondary	Change in haemoglobin A1c (HbA1c)	Measured in percentage	Baseline, 52 weeks
Secondary	Total daily dose of insulin	Measured as units/day	52 weeks
Secondary	Number of oral glucose lowering agents	Measured as count	52 weeks
Secondary	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	52 weeks
Secondary	Proportion of participants with mean glucose <154 mg/dL and <1% time below range <54 mg/dL	Measured in percentage	52 weeks
Secondary	Number of participants with Severe hypoglycemia	Measured in count	52 weeks
Secondary	Change in body weight	Measured in kilograms	Baseline, 52 weeks
Secondary	Change in waist circumference	Measured in centimeters	Baseline, 52 weeks
Secondary	Change in percentage total body fat	Measured in percentage	Baseline, 52 weeks
Secondary	Change in percentage lean mass	Measured in percentage	Baseline, 52 weeks
Secondary	Change in Inter-dialysis weight gain	Measured in kilograms	Baseline, 52 weeks
Secondary	Number of participants hospitalized	Measured in count	52 weeks
Secondary	Total number of days spent in hospital	Measured in count	52 weeks
Secondary	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.	52 weeks
Secondary	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	52 weeks
Secondary	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.").	52 weeks