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New treatment option for Diabetic Kidney Disease
Official title Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
ClinicalTrials.gov ID: NCT05822609
What this study is testing
What is Semaglutide?
Semaglutide is an investigational medicine, given as an once-daily, being studied as a potential treatment for diabetic kidney disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Personal history of pancreatitis
- Current/planned pregnancy or nursing
See the full eligibility 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
- 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...
- 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)...
- 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 assigned by chance in this trial
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Seattle, Washington, United States
- Spokane, Washington, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Seattle, Washington, United States; Spokane, Washington, United States; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.