Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06269107
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-02-13
Brief Title:
A Research Study to See How Well New Weekly Medicine IcoSema Which is a Combination of Insulin Icodec and Semaglutide Controls Blood Sugar Levels in People With Type 2 Diabetes T2D Compared to Daily Insulin Glargine COMBINE 4
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A 40-week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 UnitsmL in Participants With Type 2 Diabetes Inadequately Controlled on Oral Anti Diabetic Drugs COMBINE 4
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:
COMBINE 4
Brief Summary:
This study will compare the new medicine IcoSema which is a combination of insulin icodec and semaglutide taken once a week to insulin glargine mentioned as insulin glargine in this form taken daily in people with type 2 diabetes The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines Participant will either get IcoSema or insulin glargine Which treatment participants get is decided by chance IcoSema is a new medicine that doctors cannot prescribe Doctors can already prescribe insulin glargine in many countries The study will last for about 11 months 47 weeks
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 |
|---|---|---|---|
| U1111-1283-8648 | OTHER | None | None |
| 2022-502484-38-00 | OTHER | European Medicines Agency EMA | None |