Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

Launched by UNIVERSITY OF WASHINGTON · Apr 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called semaglutide to see how it affects kidney health and function in adults with type 1 diabetes who also have diabetic kidney disease. The main goal is to find out if semaglutide can improve oxygen levels and overall kidney performance. Additionally, researchers want to learn about its effects on blood sugar levels and safety for participants.

To be eligible for the trial, participants must be at least 18 years old, have had type 1 diabetes for at least 5 years, and show signs of kidney disease based on specific urine tests. They should also have stable blood pressure and cholesterol medication for at least 4 weeks before joining the study. Participants will undergo regular assessments and may receive the study drug, with close monitoring for any side effects. If you or someone you know meets these criteria and is interested in learning more, this study could be an opportunity to help advance treatment for diabetic kidney disease.

Gender

ALL

Eligibility criteria

• 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 ≥ 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
• 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
• • 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