Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865770
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2021-04-26
Brief Title:
A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease the REMODEL Trial
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
Renal Mode of Action of Semaglutide in Patients With Type 2 Diabetes and Chronic Kidney Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMODEL
Brief Summary:
We are doing this study to learn more about how semaglutide may help fight chronic kidney disease in people with type 2 diabetes We are doing this by looking into how semaglutide works in the kidneys
Participants will either get semaglutide or placebo a dummy medicine - which treatment participants get is decided by chance
Semaglutide is a medicine doctors can prescribe in some countries for the treatment of type 2 diabetes
Participants will get the study medicine in a pen Participants will use the pen to inject the medicine into the skin once a week
The study will last for about 1 year Participants will have 11 visits to the clinic and 2 phone visits Some of the visits could be in different locations
Study staff will take blood samples at most of these visits At 9 visits participants will be asked to bring a sample of their first morning urine At 4 of the visits participants will have to bring urine that they have collected over the last 24 hours
The study includes magnetic resonance imaging MRI scans of participants kidneys which is a test that shows a detailed picture of organs and other parts inside the body The scan will last for 30 minutes and is free of radiation
Participants will either get semaglutide or placebo a dummy medicine - which treatment participants get is decided by chance
Semaglutide is a medicine doctors can prescribe in some countries for the treatment of type 2 diabetes
Participants will get the study medicine in a pen Participants will use the pen to inject the medicine into the skin once a week
The study will last for about 1 year Participants will have 11 visits to the clinic and 2 phone visits Some of the visits could be in different locations
Study staff will take blood samples at most of these visits At 9 visits participants will be asked to bring a sample of their first morning urine At 4 of the visits participants will have to bring urine that they have collected over the last 24 hours
The study includes magnetic resonance imaging MRI scans of participants kidneys which is a test that shows a detailed picture of organs and other parts inside the body The scan will last for 30 minutes and is free of radiation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000828-19 | EUDRACT_NUMBER | World Health Organization WHO | None |
| U1111-1248-7912 | OTHER | None | None |