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Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes (RT1D)

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ClinicalTrials.gov Identifier: NCT05822609
Recruitment Status : Not yet recruiting
First Posted : April 21, 2023
Last Update Posted : February 2, 2024
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
University of Colorado, Denver
Providence Healthcare
University of Toronto
Information provided by (Responsible Party):
Ian deBoer, University of Washington

Study Description
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Brief Summary:
The primary objective of this study is to determine the effects of semaglutide on kidney oxygenation and function in type 1 diabetes. The secondary objective is to determine the glycemic effects and safety of semaglutide in type 1 diabetes.

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Type 1 Diabetes Drug: Semaglutide Other: Placebo Phase 2

Detailed Description:

A parallel-group, double-blind, placebo-controlled, randomized study will rigorously test effects of semaglutide on the kidney. Real-time continuous glucose monitoring will be used to control glycemia during study run-in (prior to randomization) and during active therapy, which investigators anticipate will lead to similar glycemic control according to treatment assignment and ability to assess effects independent of glycemia. 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.

Study Aims and Hypotheses:

Aim 1: Determine the effects of semaglutide vs. placebo on kidney oxygenation in type 1 diabetes. Hypothesis 1: Semaglutide will improve kidney oxygen availability in adults with type 1 diabetes.

Aim 2: Determine the effects of semaglutide vs. placebo on urine albumin-creatinine ratio and estimated glomerular filtration rate in type 1 diabetes. Hypothesis 2: Semaglutide will lower albuminuria and slow estimated glomerular filtration rate decline in adults with type 1 diabetes.

Aim 3: Determine the glycemic effects and safety of semaglutide vs. placebo in type 1 diabetes. Hypothesis 3: Semaglutide will reduce total daily insulin dose and improve glycemic variability without increasing risk of severe hypoglycemia or diabetic ketoacidosis in adults with type 1 diabetes.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
Estimated Study Start Date : April 2024
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Semaglutide
Semaglutide group from 0.25mg to 1.0mg
 Drug: Semaglutide
1.0 mg
Placebo Comparator: Placebo
Placebo group
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change in kidney cortical relaxation rates (R2*) [ Time Frame: Baseline to 26 weeks ]
    Measurement of oxygenation by magnetic resonance imaging


Secondary Outcome Measures :
  1. Change in urine albumin excretion [ Time Frame: Baseline to 26 weeks ]
    Measured as mean of multiple urine albumin-creatinine ratio measurements in spot urine

  2. Change in estimated glomerular filtration rate [ Time Frame: Baseline to 26 weeks ]
    Estimated glomerular filtration rate will be calculated from age, sex, and the serum concentrations of creatinine and cystatin C

  3. Change in glucose time in range [ Time Frame: Baseline to 26 weeks ]
    Proportion of time with glucose 70-180 mg/dL measured by continuous glucose monitoring

  4. Change in glucose coefficient of variation [ Time Frame: Baseline to 26 weeks ]
    Measured by continuous glucose monitoring

  5. Change in total daily insulin dose [ Time Frame: Baseline to 26 weeks ]
    Mean total dose of insulin administered per day


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05822609


Contacts
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Contact: Jennifer Tsing 310-349-9035 jtsing@uw.edu
Contact: Ernie Ayers, MSPH ayerse@uw.edu

Sponsors and Collaborators
University of Washington
Juvenile Diabetes Research Foundation
University of Colorado, Denver
Providence Healthcare
University of Toronto
Investigators
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Principal Investigator: Ian de Boer, MD, MS University of Washington
Principal Investigator: Petter Bjornstad, MD Children's Hospital Colorado
Principal Investigator: David Cherney, PhD, MD University of Toronto
Principal Investigator: Irl Hirsch, MD University of Washington
Principal Investigator: Katherine Tuttle, MD Providence Healthcare
More Information
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Responsible Party: Ian deBoer, Professor, School of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT05822609    
Other Study ID Numbers: STUDY00016349
First Posted: April 21, 2023    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study team will field direct requests from other researchers to share deidentified data after completion of the trial.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ian deBoer, University of Washington:
Glucagon-like peptide-1 receptor agonist
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Autoimmune Diseases
Immune System Diseases
Diabetes Complications
Semaglutide
Glucagon-Like Peptide-1 Receptor Agonists
Hypoglycemic Agents
Physiological Effects of Drugs