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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have been on dialysis for more than 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in TIR (70-180 mg/dl)

Secondary outcome measures

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%

Study treatment Arm

Overall Study

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

2019

Completed Phase 4

~5160

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER

1,508 Previous Clinical Trials

4,190,668 Total Patients Enrolled

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,578 Total Patients Enrolled

Ildiko Lingvay, MD, MPH, MSCSPrincipal InvestigatorUT Southwestern Medical Center

2 Previous Clinical Trials

123 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals currently being accepted into this research trial?

"As per the details available on clinicaltrials.gov, this medical trial is not currently enrolling patients. Initially posted in December of 2023 and last updated in September of the same year; while presently inactive, there are 595 other studies actively recruiting participants at present."

Answered by AI

To what degree do the risks posed by Arm 1 - Semaglutide outweigh its potential benefits?

"Arm 1 - Semaglutide was given a 3 on our safety scale because it is approved for Phase 4 trials, indicating there is extensive clinical data to support its security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DIALYSIS-TIR Study

Ildiko Lingvay 2023. "DIALYSIS-TIR Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042153.