Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05823948
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2023-04-09
Brief Title:
A Study Using Flash Glucose Measurements for a New Once-weekly Insulin Insulin Icodec in People With Type 2 Diabetes Who Have Not Used Insulin Before ONWARDS 9
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Study to Evaluate Flash Glucose Monitoring Based Titration of Once-weekly Insulin Icodec in Insulin-naïve Participants With Type 2 Diabetes
Status:
COMPLETED
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:
ONWARDS 9
Brief Summary:
This study looks at how a person with type 2 diabetes can be treated with insulin icodec and a flash glucose monitor a small sensor inserted under the skin to measure blood sugar all the time The study will look at how well insulin icodec controls blood sugar when used in combination with a flash glucose monitor Participants will get insulin icodec that they have to inject once a week on the same day of the week The insulin will be injected with a needle in a skin fold in the thigh upper arm or stomach The study will last for about 8 months Participants will have to wear a flash glucose monitor throughout the study This is a sensor that fits on arm Participants will be asked to use a commercially available app called LibreView to allow team to view flash glucose monitor data Participants will get a study phone to scan the flash glucose monitor 4 times daily and they will be able to see all of the flash glucose monitor data during the study Women cannot take part if pregnant breast-feeding or planning to get pregnant during the study period
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 |
|---|---|---|---|
| U1111-1271-9296 | OTHER | World Health Organization WHO | None |