Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

Trial ID: NCT05822609

Interventional - Phase 2 - Recruiting

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.

Conditions

• Diabetic Kidney Disease
• Type 1 Diabetes

Interventions

• Semaglutide
• Placebo

Eligibility

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

Sponsor

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

Source: ClinicalTrials.gov

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