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Placebo

Semaglutide for Type 2 Diabetes with Dialysis

Phase 4
Recruiting
Led By Ildiko Lingvay, MD, MPH, MSCS
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
On current chronic treatment with Hemodialysis or Peritoneal dialysis for > 6 months prior to screening
Be older than 18 years old
Must not have
Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetes mellitus, MODY, LADA, drug induced, etc.)
Known current uncontrolled or unstable retinopathy (by medical history)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will compare blood sugar levels of people with type 2 diabetes on dialysis taking semaglutide to those taking dummy medicine. Participants will wear a sugar sensor & inject the study med once a week for 1 year.

Who is the study for?
Adults over 18 with type 2 diabetes on dialysis for at least 6 months, currently taking stable glucose-lowering medication can join. They must have a certain blood sugar level range and not be underweight or have used GLP-1 RA drugs recently. People with specific medical conditions, severe allergies to trial meds, pregnant or not using contraception, actively losing weight, or having other types of diabetes cannot participate.
What is being tested?
The DIALYSIS-TIR Study is testing if semaglutide helps control blood sugar better than a placebo in people with type 2 diabetes who are on chronic dialysis. Participants will inject the medicine once weekly for over a year and wear a glucose sensor periodically to monitor changes.
What are the potential side effects?
Semaglutide may cause side effects like digestive issues (nausea, vomiting), low blood sugar levels (hypoglycemia), possible allergic reactions, and rarely thyroid tumors. The placebo should not cause any direct side effects since it's inactive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on dialysis for more than 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a form of diabetes that is not type 2.
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I do not have uncontrolled or unstable eye disease.
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I or my family have a history of medullary thyroid cancer or MEN2.
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I have lost more than 5% of my weight in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in TIR (70-180 mg/dl)
Secondary study objectives
Change in Inter-dialysis weight gain
Change in Time in high range (180-250 mg/dl)
Change in Time in low range (54-69 mg/dl)
+22 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1 - SemaglutideExperimental Treatment1 Intervention
Participants will receive semaglutide as an adjunct to standard-of-care.
Group II: Arm 2- PlaceboPlacebo Group1 Intervention
Participants will receive placebo (semaglutide) as an adjunct to standard-of-care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER
1,552 Previous Clinical Trials
4,292,669 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,079 Previous Clinical Trials
1,056,007 Total Patients Enrolled
Ildiko Lingvay, MD, MPH, MSCSPrincipal InvestigatorUT Southwestern Medical Center
2 Previous Clinical Trials
123 Total Patients Enrolled
~78 spots leftby Sep 2025
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