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DIALYSIS-TIR Study

Primary Purpose

Type 2 Diabetes, End Stage Renal Disease on Dialysis

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Semaglutide
Placebo
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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% Exclusion Criteria: 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 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)

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1 - Semaglutide

Arm 2- Placebo

Arm Description

Participants will receive semaglutide as an adjunct to standard-of-care.

Participants will receive placebo (semaglutide) as an adjunct to standard-of-care.

Outcomes

Primary Outcome Measures

Change in TIR (70-180 mg/dl)
Measured in percentage by Continuous glucose monitor (CGM)

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2023
Last Updated
September 11, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT06042153
Brief Title
DIALYSIS-TIR Study
Official Title
Semaglutide for Dialysis-Treated Patients - a Glucose Time in Range Study- DIALYSIS-TIR Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
University of North Carolina, Chapel Hill

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, End Stage Renal Disease on Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled, trial comparing semaglutide subcutaneously weekly versus matched placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
157 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - Semaglutide
Arm Type
Experimental
Arm Description
Participants will receive semaglutide as an adjunct to standard-of-care.
Arm Title
Arm 2- Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo (semaglutide) as an adjunct to standard-of-care.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Change in TIR (70-180 mg/dl)
Description
Measured in percentage by Continuous glucose monitor (CGM)
Time Frame
Baseline, 52 weeks
Secondary Outcome Measure Information:
Title
Change in Time in high range (180-250 mg/dl)
Description
Measured in percentage by Continuous glucose monitor (CGM)
Time Frame
Baseline, 52 weeks
Title
Change in Time in very high range (>250 mg/dl)
Description
Measured in percentage by Continuous glucose monitor (CGM)
Time Frame
Baseline, 52 weeks
Title
Change in Time in low range (54-69 mg/dl)
Description
Measured in percentage by Continuous glucose monitor (CGM)
Time Frame
Baseline, 52 weeks
Title
Change in Time in very low range (<54 mg/dl)
Description
Measured in percentage by Continuous glucose monitor (CGM)
Time Frame
Baseline, 52 weeks
Title
Proportion of participants with TIR 70-180 mg/dl for 70% of the day
Description
Measured in percentage by CGM
Time Frame
52 weeks
Title
Proportion of participants with TIR 70-180 mg/dl with more than equal to 5% improvement from baseline
Description
Measured in percentage by CGM
Time Frame
52 weeks
Title
Proportion of participants with Time below range <70 mg/dL for <4% of each day
Description
Measured in percentage by CGM
Time Frame
52 weeks
Title
Proportion of participants with Time below range <54 mg/dL for <1% of each day
Description
Measured in percentage by CGM
Time Frame
52 weeks
Title
Proportion of participants with Time above range >180 mg/dL for <25% of each day
Description
Measured in percentage by CGM
Time Frame
52 weeks
Title
Change in haemoglobin A1c (HbA1c)
Description
Measured in percentage
Time Frame
Baseline, 52 weeks
Title
Total daily dose of insulin
Description
Measured as units/day
Time Frame
52 weeks
Title
Number of oral glucose lowering agents
Description
Measured as count
Time Frame
52 weeks
Title
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%
Description
Measured in percentage
Time Frame
52 weeks
Title
Proportion of participants with mean glucose <154 mg/dL and <1% time below range <54 mg/dL
Description
Measured in percentage
Time Frame
52 weeks
Title
Number of participants with Severe hypoglycemia
Description
Measured in count
Time Frame
52 weeks
Title
Change in body weight
Description
Measured in kilograms
Time Frame
Baseline, 52 weeks
Title
Change in waist circumference
Description
Measured in centimeters
Time Frame
Baseline, 52 weeks
Title
Change in percentage total body fat
Description
Measured in percentage
Time Frame
Baseline, 52 weeks
Title
Change in percentage lean mass
Description
Measured in percentage
Time Frame
Baseline, 52 weeks
Title
Change in Inter-dialysis weight gain
Description
Measured in kilograms
Time Frame
Baseline, 52 weeks
Title
Number of participants hospitalized
Description
Measured in count
Time Frame
52 weeks
Title
Total number of days spent in hospital
Description
Measured in count
Time Frame
52 weeks
Title
Total score of Diabetes Treatment Satisfaction questionnaire
Description
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.
Time Frame
52 weeks
Title
Total score of EQ-5D-5L
Description
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
Time Frame
52 weeks
Title
Total score of Kidney disease QoL short form
Description
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.").
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% Exclusion Criteria: 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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marielle Berger-Nagele, MS
Phone
214-648-2363
Email
marielle.berger-nagele@utsouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ileana Cuevas, PhD
Phone
214-648-2321
Email
ileana.cuevas@utsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ildiko Lingvay, MD, MPH, MSCS
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Kass, MSN, MBA, RN
Phone
984-974-3009
Email
alex_kass@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Klara Klein, MD
Phone
9849743004
Email
klara_klein@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Klara Klein, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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DIALYSIS-TIR Study

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