RECRUITING

Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

Conditions

Diabetic Kidney Disease Type 1 Diabetes Glucagon-like peptide-1 receptor agonist

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to determine the effects of semaglutide on kidney oxygenation and function in type 1 diabetes. The secondary objective is to determine the glycemic effects and safety of semaglutide in type 1 diabetes.

Official Title

Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

Quick Facts

Study Start:2024-04-05

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05822609

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 ≥ 45 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	* 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 * Inability to cooperate with or clinical contraindication for magnetic resonance imaging including severe claustrophobia, nonremovable devices, implanted metal * 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

Inclusion Criteria

Exclusion 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 ≥ 45 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

* 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
* Inability to cooperate with or clinical contraindication for magnetic resonance imaging including severe claustrophobia, nonremovable devices, implanted metal
* 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

Contacts and Locations

Study Contact

Julie Porter

CONTACT

206-897-4728

jporter7@uw.edu

Ernest Ayers, MSPH

CONTACT

206-685-1423

ayerse@uw.edu

Principal Investigator

Ian de Boer, MD, MS

PRINCIPAL_INVESTIGATOR

University of Washington

Jessica Kendrick, MD

PRINCIPAL_INVESTIGATOR

University of Colorado Anschutz Medical Campus and Children's Hospital Colorado

David Cherney, PhD, MD

PRINCIPAL_INVESTIGATOR

University of Toronto

Irl Hirsch, MD

PRINCIPAL_INVESTIGATOR

University of Washington

Katherine Tuttle, MD

PRINCIPAL_INVESTIGATOR

Providence Healthcare

Study Locations (Sites)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

University of Washington

Seattle, Washington, 98104

United States

Providence Sacred Heart Medical Center

Spokane, Washington, 99204

United States

Collaborators and Investigators

Sponsor: University of Washington

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

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 Registration Dates

Study Start Date2024-04-05

Study Completion Date2026-06

Study Record Updates

Study Start Date2024-04-05

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

Glucagon-like peptide-1 receptor agonist

Additional Relevant MeSH Terms

Diabetic Kidney Disease
Type 1 Diabetes