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Semaglutide for Chronic Kidney Disease in Type 2 Diabetes (FLOW 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
Renal impairment defined by specific eGFR and UACR criteria
Diagnosed with type 2 diabetes mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, year 3
Awards & highlights

FLOW Trial Summary

This trial is testing whether semaglutide can help slow down the progression of kidney disease in people with type 2 diabetes. Participants will be given either semaglutide or a placebo, and neither they nor the researchers will know who is receiving which. The study will last for 3-5 years.

Who is the study for?
Adults with type 2 diabetes and chronic kidney disease can join this study. They must have specific levels of renal function, be on a stable dose of RAAS blocking agents unless not tolerated, and have an HbA1c ≤10%. People with severe heart failure, unstable eye disease from diabetes, recent major cardiovascular events or dialysis treatment, hereditary kidney diseases, or those who've used GLP-1 receptor agonists recently cannot participate.Check my eligibility
What is being tested?
The trial is testing if semaglutide can slow the progression of chronic kidney disease in people with type 2 diabetes. Participants will either receive semaglutide or a placebo through weekly injections using a pen. The assignment to either group is random. The study duration ranges from 3 to 5 years until enough data is gathered for conclusive results.See study design
What are the potential side effects?
While the trial description doesn't list side effects specifically for semaglutide, common ones may include nausea, vomiting, diarrhea, abdominal pain and possibly low blood sugar when combined with other diabetes medications.

FLOW Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney function is not normal, based on specific tests.
Select...
I have been diagnosed with type 2 diabetes.

FLOW Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, year 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, year 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first occurrence of a composite event defined as persistent eGFR decline of greater than or equal to 50 percentage from trial start, reaching ESRD, death from kidney disease or death from cardiovascular disease
Secondary outcome measures
Annual rate of change in eGFR (CKD-EPI) (chronic eGFR slope)
Annual rate of change in eGFR (chronic kidney disease - epidemiology collaboration (CKD-EPI)) (total eGFR slope)
Change in body weight
+11 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

FLOW Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
Participants are to receive semglutide for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.
Group II: PlaceboPlacebo Group1 Intervention
Participants are to receive placebo (semglutide) for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,411,521 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
41,612 Total Patients Enrolled

Media Library

Placebo (semaglutide) Clinical Trial Eligibility Overview. Trial Name: NCT03819153 — Phase 3
Type 2 Diabetes Research Study Groups: Semaglutide, Placebo
Type 2 Diabetes Clinical Trial 2023: Placebo (semaglutide) Highlights & Side Effects. Trial Name: NCT03819153 — Phase 3
Placebo (semaglutide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03819153 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT03819153 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you elaborate on the risks associated with Semaglutide?

"Semaglutide was given a safety rating of 3. This is due to the fact that it is a Phase 3 drug, meaning that there is some data to support its efficacy, as well as multiple rounds of data supporting its safety."

Answered by AI

How many individuals are being closely monitored in this clinical trial?

"This particular trial is no longer recruiting patients. The study was initially posted on June 17th, 2019 and experienced its most recent update on January 26th, 2022. If you are seeking other trials, 1914 studies for patients with diabetes mellitus, type 2 and 59 studies for Semaglutide are currently enrolling participants."

Answered by AI

Can you give me an estimate of how many different hospitals are participating in this research project?

"There are a total of 100 sites running this trial. While some are located in Quebec, Scarborough and Stoney Creek, there are many other clinics participating located throughout other cities. If you are selected for this trial, it is important to try and be assigned to a clinic that is close to you to avoid excessive travel."

Answered by AI

Are there any open positions for participants in this research project?

"Unfortunately, at this moment in time, this clinical trial is not looking for more patients. The study was first posted on 6/17/2019, with the most recent update on 1/26/2022. However, if you are interested in other studies, there are 1914 trials for patients with diabetes mellitus type 2 and 59 trials for Semaglutide that are actively recruiting participants."

Answered by AI

Are there other instances where Semaglutide has been used in medical research?

"Currently, 27 out of 59 total clinical trials for Semaglutide are in Phase 3. While a concentration of these studies are in Loma Linda, CA, there are actually 3696 research centres running these tests."

Answered by AI

What are the main reasons that doctors prescribe Semaglutide to their patients?

"Semaglutide is the most popular medication for chronic weight management. This drug can also assist patients following a reduced-calorie diet and exercise plan who have at least one additional weight-related health complication."

Answered by AI

Does this clinical trial represent a new development in medical research?

"Novo Nordisk A/S sponsored the initial clinical trial for Semaglutide in 2018. This Phase 4 study involved 1387 participants and completed drug approval in 2018. Since then, there have been 124 completed studies and 59 active studies for Semaglutide across 711 cities and 55 countries."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0

What questions have other patients asked about this trial?

Is this a paid trial? How long are screening visits? How frequent are screening visits? What time of day are they available?
PatientReceived no prior treatments

Why did patients apply to this trial?

to get better treatment. I was on trulicity for 3 years. Metformin I need better treatment.
PatientReceived no prior treatments
Would like to find new ways to fix. Help advanced the treatment of CKD.
PatientReceived no prior treatments
Recent research and studies
Current Diabetes ReportsJournal
Mineralocorticoid Receptor Antagonists in the Treatment of Diabetic Kidney Disease: Their Application in the Era of SGLT2 Inhibitors and GLP-1 Receptor Agonists
Cohen, Scott, Hillel Sternlicht, and George L. Bakris. 2022. “Mineralocorticoid Receptor Antagonists in the Treatment of Diabetic Kidney Disease: Their Application in the Era of SGLT2 Inhibitors and GLP-1 Receptor Agonists”. Current Diabetes Reports. Springer Science and Business Media LLC. doi:10.1007/s11892-022-01461-4.
clinicaltrials.govStudy
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
2019. "A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03819153.
All > Chronic Kidney Disease > Type 2 Diabetes
~170 spots leftby Aug 2024
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