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

May 29, 2026 updated by: Ian deBoer, University of Washington
The primary objective of this study is to determine the effects of semaglutide on change in albuminuria from baseline to 26 weeks in type 1 diabetes. The secondary objective is to determine the effects of semaglutide on change in kidney parameters (including kidney oxygenation and function) measured by MRI from baseline to 26 weeks in type 1 diabetes. Other objectives are to determine the glycemic effects and safety of semaglutide in type 1 diabetes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A parallel-group, double-blind, placebo-controlled, randomized study will rigorously test effects of semaglutide on the kidney. Real-time continuous glucose monitoring will be used to control glycemia during study run-in (prior to randomization) and during active therapy, which investigators anticipate will lead to similar glycemic control according to treatment assignment and ability to assess effects independent of glycemia. The trial duration is 26 weeks, a period of time sufficient to gradually titrate study medications to maximum target dose (over 12 weeks) and then observe the full short-term effect of semaglutide on the kidney.

Study Aims and Hypotheses:

Aim 1: Determine the effects of semaglutide vs. placebo on kidney oxygenation in type 1 diabetes. Hypothesis 1: Semaglutide will improve kidney oxygen availability in adults with type 1 diabetes.

Aim 2: Determine the effects of semaglutide vs. placebo on urine albumin-creatinine ratio and estimated glomerular filtration rate in type 1 diabetes. Hypothesis 2: Semaglutide will lower albuminuria and slow estimated glomerular filtration rate decline in adults with type 1 diabetes.

Aim 3: Determine the glycemic effects and safety of semaglutide vs. placebo in type 1 diabetes. Hypothesis 3: Semaglutide will reduce total daily insulin dose and improve glycemic variability without increasing risk of severe hypoglycemia or diabetic ketoacidosis in adults with type 1 diabetes.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ernest Ayers, MSPH
  • Phone Number: 206-685-1423
  • Email: ayerse@uw.edu

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2N2
        • Recruiting
        • Toronto General Hospital, University Health Network
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Cherney, MD CM PhD
  • United States
    • Colorado
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • Irl Hirsch, MD
        • Contact:
          • Dori Khakpour, RDN CDE
          • Phone Number: 206-945-4954
          • Email: dorik@uw.edu
        • Contact:
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center
        • Principal Investigator:
          • Katherine Tuttle, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (≥18 years) with type 1 diabetes
  • Diabetes duration of ≥5 years
  • Persistent urine albumin-to-creatinine ratio (UACR) ≥ 30 mg/g, on the most recent two measurements within the prior 3 years
  • Estimated glomerular filtration rate ≥ 20 mL/min/1.73m2
  • Stable doses of drugs altering blood pressure (e.g., Angiotensin-converting enzyme inhibitor) required for at least 4 weeks prior to randomization, and requested for the duration of the trial
  • Stable doses of lipid-lowering medications required for at least 4 weeks prior to randomization, and requested for the duration of the trial
  • Adequate contraceptive method for females of child-bearing potential

Exclusion Criteria:

  • HbA1c >9%, recent diabetic ketoacidosis, hyperosmolar hyperglycemic state or severe illness requiring hospitalization in past 30 days
  • Other causes of diabetes mellitus, including type 2 diabetes and maturity-onset diabetes of the young (MODY)
  • Chronic kidney disease unrelated to diabetes
  • Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) or thyroid nodule palpated by endocrinologist at screening
  • Personal history of pancreatitis
  • Current/planned pregnancy or nursing
  • Uncontrolled thyroid disease or hypertension (Systolic blood pressure [SBP] ≥ 160 mm Hg or diastolic blood pressure [DBP] ≥ 100 mm Hg despite treatment)
  • Proliferative retinopathy with treatment in the past 6 months
  • Uncontrolled or potentially unstable diabetic retinopathy or maculopathy, verified by fundus examination with pupil dilation unless performed using a digital fundus photography camera specified for non-dilated examination
  • More than 2 severe hypoglycemic episodes (requiring glucagon and/or assistance from another person) in the past 6 months
  • Frequent hypoglycemia during the last two weeks of the study run-in phase (time below range [<70 mg/dL] ≥4%)
  • Pramlintide and the use of glycemia treatments not approved for type 1 diabetes by the FDA, e.g., metformin, SGT-2 inhibitor, GLP-1 receptor agonist, closed loop insulin delivery using unapproved algorithms
  • Significant systemic conditions or treatment such as cancer or immunomodulators
  • Known liver disease other than non-alcoholic fatty liver disease (NAFLD) or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >100 IU/L, history of severe gastrointestinal disease (e.g., gastroparesis) or gallstones
  • Body mass index <20 kg/m2
  • Known or suspected allergy/sensitivity to semaglutide or its excipients
  • Pregnant, breast feeding, or the intention of becoming pregnant
  • The receipt of any investigational drug within 3 months prior to this trial
  • Previously randomized in this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo group
Other: Placebo
Placebo
Experimental: Semaglutide
Semaglutide group from 0.25mg to 1.0mg
Drug: Semaglutide
1.0 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urine albumin excretion
Time Frame: Baseline to 26 weeks
Measured as mean of multiple urine albumin-creatinine ratio measurements in spot urine
Baseline to 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in estimated glomerular filtration rate
Time Frame: Baseline to 26 weeks
Estimated glomerular filtration rate will be calculated from age, sex, and the serum concentrations of creatinine and cystatin C
Baseline to 26 weeks
Change in glucose time in range
Time Frame: Baseline to 26 weeks
Proportion of time with glucose 70-180 mg/dL measured by continuous glucose monitoring
Baseline to 26 weeks
Change in glucose coefficient of variation
Time Frame: Baseline to 26 weeks
Measured by continuous glucose monitoring
Baseline to 26 weeks
Change in total daily insulin dose
Time Frame: Baseline to 26 weeks
Mean total dose of insulin administered per day
Baseline to 26 weeks
Change in kidney cortical relaxation rates (R2*)
Time Frame: Baseline to 26 weeks
Measurement of oxygenation by magnetic resonace imaging
Baseline to 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

University of Colorado, Denver
Juvenile Diabetes Research Foundation
University of Toronto
Providence Healthcare

Investigators

  • Principal Investigator: Irl Hirsch, MD, University of Washington
  • Principal Investigator: David Cherney, PhD, MD, University of Toronto
  • Principal Investigator: Katherine Tuttle, MD, Providence Healthcare
  • Principal Investigator: Ian de Boer, MD, MS, University of Washington
  • Principal Investigator: Jessica Kendrick, MD, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00016349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study team will field direct requests from other researchers to share deidentified data after completion of the trial.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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