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Semaglutide for Type 2 Diabetes with Chronic Kidney Disease (REMODEL Trial)
Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age above or equal to 18 years at the time of signing informed consent.
For subjects in the biopsy sub-population: Serum creatinine-based eGFR greater than or equal to 40 and below or equal to 75 mL/min/1.73 m^2(CKD-EPI)
Must not have
Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
Combination use of an ACE (angiotensin-converting enzyme) inhibitor and an ARB (angiotensin II receptor blockers)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of treatment (week 52
Awards & highlights
Summary
This trial is testing if semaglutide can help fight chronic kidney disease in people with type 2 diabetes. Participants will be randomly assigned to receive either semaglutide or placebo, and will be monitored for a year through clinic visits and phone calls. Blood and urine samples will be taken, and participants will also have MRI scans.
Who is the study for?
Adults with type 2 diabetes and chronic kidney disease can join this study. They must have a certain level of albumin in their urine, stable kidney function within specific limits, and controlled blood sugar levels. Participants should be on steady doses of medication for kidney protection but cannot have used certain diabetes drugs recently or have had recent major cardiovascular events.
What is being tested?
The REMODEL trial is testing Semaglutide against a placebo to see if it helps the kidneys in people with type 2 diabetes. Patients will inject themselves weekly for about a year, attend clinic visits, provide urine samples, and undergo MRI scans of their kidneys.
What are the potential side effects?
While not specified here, common side effects of Semaglutide may include nausea, vomiting, diarrhea, abdominal pain and loss of appetite. Side effects from MRIs are rare but could include discomfort or reactions to contrast agents if used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My kidney function, measured by eGFR, is between 40 and 75 mL/min.
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My kidney function, measured by eGFR, is between 30 and 75 mL/min.
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I have been on a stable dose of ACE inhibitor or ARB for at least 28 days.
Select...
I am 18 years old or older.
Select...
My kidney function, measured by eGFR, is between 30 and 75 mL/min.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a genetic or autoimmune kidney disease, like polycystic kidney disease or glomerulonephritis.
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I am taking both an ACE inhibitor and an ARB medication.
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I haven't had cancer, except for certain skin, cervical, or prostate cancers, in the last 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (week 0) to end of treatment (week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of treatment (week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in global kidney perfusion (MRI)
Change in kidney inflammation (cortex), T1 mapping (MRI)
Change in kidney inflammation (medulla), T1 mapping (MRI)
+2 moreSecondary study objectives
Change in ADC (apparent diffusion coefficient) (cortex) (MRI)
Change in ADC (medulla) (MRI)
Change in albumin excretion rate (urinalysis)
+6 moreSide effects data
From 2020 Phase 4 trial • 104 Patients • NCT0418984821%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide 1.0 mg OWExperimental Treatment1 Intervention
Once-weekly (OW) Semaglutide administered subcutaneously (s.c., under the skin).
Group II: Placebo (Semaglutide) 1.0 mg OWPlacebo Group1 Intervention
Once-weekly (OW) placebo (Semaglutide) administered subcutaneously (s.c., under the skin).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,541 Previous Clinical Trials
2,440,965 Total Patients Enrolled
Clinical Transparency (Dept.1452)Study DirectorNovo Nordisk A/S
3 Previous Clinical Trials
658 Total Patients Enrolled
Clinical Transparency (Dept.2834)Study DirectorNovo Nordisk A/S
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any strong anti-inflammatory or immunosuppressant drugs in the last 3 months, except for aspirin for my heart or occasional ibuprofen.I haven't had a heart attack, stroke, or severe heart issues in the last 6 months.I have been on a stable dose of ACE inhibitor or ARB for at least 28 days.You have had an organ transplant in the past, or you are waiting to have an organ transplant.I am 18 years old or older.I was diagnosed with type 2 diabetes more than 6 months ago.I have a genetic or autoimmune kidney disease, like polycystic kidney disease or glomerulonephritis.My kidney function, measured by eGFR, is between 40 and 75 mL/min.My kidney function, measured by eGFR, is between 30 and 75 mL/min.I have been on a stable dose of ACE inhibitor or ARB for at least 28 days.I do not have unstable diabetic eye problems verified by a recent eye exam.You are unable to have a MRI scan due to reasons like claustrophobia, metal implants, or certain types of tattoos.I was diagnosed with type 2 diabetes more than 6 months ago.I am taking both an ACE inhibitor and an ARB medication.I have not used any GLP-1 receptor agonists in the last 30 days.Your UACR test result is between 20 and 5000 mg/g.I am either male or female.Your HbA1c level is 9.0 percent or lower.I haven't had cancer, except for certain skin, cervical, or prostate cancers, in the last 5 years.Your HbA1c level is 9.0 percent or lower (75 mmol/mol or lower).I am either male or female.I am 18 years old or older.Your UACR test shows a level of albumin in your urine that is between 20 and 5000 mg/g.My kidney function, measured by eGFR, is between 30 and 75 mL/min.
Research Study Groups:
This trial has the following groups:- Group 1: Semaglutide 1.0 mg OW
- Group 2: Placebo (Semaglutide) 1.0 mg OW
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04865770 — Phase 3
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