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RecruitingPhase 2

Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The trial duration is 26 weeks, a period of time sufficient to gradually titrate study medications to maximum target dose (over 12 weeks) and then observe the full short-term effect of semaglutide on the kidney."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests semaglutide in adults with type 1 diabetes and kidney disease caused by diabetes. Over 26 weeks, it will check changes in protein in the urine and use MRI scans to study kidney oxygen levels and function. It will also check blood sugar effects and safety.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old and have had type 1 diabetes for at least 5 years.
  • Your two most recent urine tests within the past 3 years show a protein level called UACR of at least 30 mg/g.
  • Your estimated kidney filtering rate, called eGFR, is at least 20 mL/min/1.73 m².
  • Your doses of medicines that affect blood pressure have been stable for at least 4 weeks before study group assignment. You will be asked to keep them stable during the study.
  • Your doses of cholesterol-lowering medicines have been stable for at least 4 weeks before study group assignment. You will be asked to keep them stable during the study.
  • If you can become pregnant, you must use an adequate birth control method.

Who can't join

  • Your HbA1c, a measure of average blood sugar, is above 9%; you recently had a dangerous diabetes crisis involving acid buildup or very high blood sugar; or you had a severe illness needing a hospital stay in the past 30 days.
  • You have another type of diabetes, kidney disease not caused by diabetes, uncontrolled thyroid disease, or blood pressure of 160 or higher on top or 100 or higher on bottom despite treatment.
  • You or a family member has had medullary thyroid cancer or MEN 2, a condition that causes tumors in hormone-making glands; a thyroid lump is felt at screening; or you have had pancreatitis, which is swelling of the pancreas.
  • You have advanced diabetes-related eye disease treated in the past 6 months, or uncontrolled or possibly unstable diabetes-related eye damage. You had more than 2 severe low-blood-sugar episodes needing glucagon or another person's help in the past 6 months, or blood sugar below 70 mg/dL at least 4% of the time during the last 2 weeks of the study's preparation phase.
  • You use pramlintide, blood sugar treatments not FDA-approved for type 1 diabetes, or an automated insulin system with unapproved dosing software. You have a serious body-wide condition, such as cancer, or receive treatment such as medicines that change immune system activity.
  • You have liver disease other than non-alcoholic fatty liver disease, liver blood tests called AST or ALT above 100 IU/L, a history of severe stomach or bowel disease such as slow stomach emptying, or gallstones.
  • Your body mass index, a measure based on height and weight, is below 20; you have a known or suspected allergy to semaglutide or its ingredients; or you are pregnant, breastfeeding, or planning pregnancy.
  • You received an experimental drug within the past 3 months or were already assigned to a group in this trial.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 ≥ 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

Study sites (3)

CO

WA