Effects of Semaglutide on Kidney Function in Type 1 Diabetes
Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
This study is testing if a medication called semaglutide can improve kidney function in adults with type 1 diabetes over 26 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 4 sites (Aurora, Colorado and 3 other locations) |
| Trial ID | NCT05822609 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with type 1 diabetes, a history of diabetes for at least 5 years, and specific kidney function criteria.
Not a fit: Patients with type 2 diabetes or other forms of diabetes, as well as those with severe recent complications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to improved kidney function and reduced complications for patients with type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with glucagon-like peptide-1 receptor agonists in diabetes management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 ≥ 30 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
Where this trial is running
Aurora, Colorado and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.