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Glucagon-like peptide-1 (GLP-1) receptor agonist

Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes (RT1D Trial)

Phase 2
Recruiting
Led By Petter Bjornstad, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable doses of lipid-lowering medications required for at least 4 weeks prior to randomization, and requested for the duration of the trial
Adults (≥18 years) with type 1 diabetes
Must not have
Personal history of pancreatitis
Other causes of diabetes mellitus, including type 2 diabetes and maturity-onset diabetes of the young (MODY)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 26 weeks

Summary

"This trial aims to see how semaglutide affects kidney function and oxygen levels in people with type 1 diabetes. It will also look at how semaglutide impacts blood sugar levels and safety

Who is the study for?
This trial is for adults over 18 with type 1 diabetes who have had the condition for at least five years and are showing signs of kidney disease. They must have stable blood pressure and cholesterol medication use, and women able to have children need to use birth control.
What is being tested?
The study tests if Semaglutide can improve kidney oxygenation and function in people with type 1 diabetes. It also looks at how it affects blood sugar levels and its overall safety compared to a placebo (a treatment with no active drug).
What are the potential side effects?
Possible side effects of Semaglutide may include nausea, vomiting, diarrhea, abdominal pain, low blood sugar events, potential allergic reactions, or injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on stable doses of my cholesterol medication for at least 4 weeks.
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I am an adult with type 1 diabetes.
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I have had diabetes for 5 years or more.
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My kidney function is normal or only mildly reduced.
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My blood pressure medication dose has been stable for at least 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had pancreatitis before.
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I have a type of diabetes that is not caused by another condition.
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My kidney disease is not caused by diabetes.
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My blood pressure is controlled and not above 160/100 mm Hg.
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My HbA1c is above 9%, or I've had severe diabetes complications or illness requiring hospitalization recently.
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I am not using unapproved diabetes treatments like metformin or SGT-2 inhibitors.
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I've had frequent low blood sugar in the last two weeks.
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I or my family have a history of specific thyroid cancer or I have a thyroid nodule.
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I've had more than 2 severe low blood sugar incidents needing help in the last 6 months.
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I do not have liver disease (except NAFLD) or severe GI issues, and my liver enzymes are normal.
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I am allergic to semaglutide or its ingredients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 26 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 kidney cortical relaxation rates (R2*)
Secondary study objectives
Change in estimated glomerular filtration rate
Change in glucose coefficient of variation
Change in glucose time in range
+2 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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
Semaglutide group from 0.25mg to 1.0mg
Group II: PlaceboPlacebo Group1 Intervention
Placebo group
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?

Juvenile Diabetes Research FoundationOTHER
235 Previous Clinical Trials
142,293 Total Patients Enrolled
Providence HealthcareOTHER
17 Previous Clinical Trials
2,889 Total Patients Enrolled
University of TorontoOTHER
725 Previous Clinical Trials
1,115,632 Total Patients Enrolled
University of Colorado, DenverOTHER
1,810 Previous Clinical Trials
2,920,040 Total Patients Enrolled
University of WashingtonLead Sponsor
1,831 Previous Clinical Trials
1,907,509 Total Patients Enrolled
Petter Bjornstad, MDPrincipal InvestigatorChildren's Hospital Colorado
6 Previous Clinical Trials
390 Total Patients Enrolled
Ian de Boer, MD, MSPrincipal InvestigatorUniversity of Washington
3 Previous Clinical Trials
117 Total Patients Enrolled
Jessica Kendrick, MDPrincipal InvestigatorUniversity of Colorado Anschutz Medical Campus and Children's Hospital Colorado
5 Previous Clinical Trials
324 Total Patients Enrolled
Katherine Tuttle, MDPrincipal InvestigatorProvidence Healthcare
David Cherney, PhD, MDPrincipal InvestigatorUniversity of Toronto
~40 spots leftby Jun 2026
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