Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813912
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-04-03
Brief Title:
A Research Study to See How a New Weekly Insulin Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Single Arm Study Investigating the Glycaemic Control and Safety of Adding Semaglutide to Insulin Icodec in Participants With Type 2 Diabetes Qualifying for Treatment Intensification
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This study looks at how a new medicine insulin icodec helps in reducing blood sugar levels when given along with semaglutide in patients with type 2 diabetes Participants will get the medicine insulin icodec once a week in the first part of the study run-in period-26 weeks Participants will only enter the second part of the study if the blood sugar levels have not reduced to normal If blood sugar levels are normal after the first 26 weeks participants will continue in a 5-week follow up period In the second part of the study intensification period-26 weeks participants will get both insulin icodec and semaglutide once weekly after which they will continue in a 5-week follow up period Participants will have to inject the study medicines once a week on the same day of the week in a skin fold in the thigh upper arm or stomach The study will last for about 13 months Participants will get a blood glucose meter to check blood sugar levels In addition participants will be asked to enter blood sugar levels in the study phone In addition Participants will be asked to enter selected few blood sugar values three times during the study in a paper diary that will be provided to participants Women cannot take part if pregnant breast-feeding or plan 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 |
|---|---|---|---|
| 2022-002847-24 | EUDRACT_NUMBER | None | None |
| U1111-1281-4752 | OTHER | World Health Organization WHO | None |