Effects of Semaglutide on Kidney Function in Type 1 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of semaglutide, a glucagon-like peptide-1 receptor agonist, on kidney oxygenation and function in adults with type 1 diabetes. It employs a parallel-group, double-blind, placebo-controlled design, where participants will be randomized to receive either semaglutide or a placebo over a 26-week period. Continuous glucose monitoring will be utilized to maintain glycemic control, allowing for an assessment of semaglutide's effects independent of blood sugar levels. The study aims to evaluate changes in kidney function, including urine albumin-creatinine ratio and estimated glomerular filtration rate, as well as glycemic control and safety outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• University of Washington
  Seattle, Washington, United States Recruiting
• Providence Sacred Heart Medical Center
  Spokane, Washington, United States Recruiting
• Toronto General Hospital, University Health Network
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Ian de Boer, MD, MS — University of Washington
• Study coordinator: Ernest Ayers, MSPH
• Email: ayerse@uw.edu
• Phone: 206-685-1423

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.