Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340854
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-03-26
Brief Title:
A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin Insulin Icodec Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes
Status:
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:
None
Brief Summary:
This study compares insulin icodec a new insulin taken once a week to insulin glargine an insulin taken once a day The study medicine will be investigated in participants with type 2 diabetes Participants will either get insulin icodec or insulin glargine Which treatment participants get is decided by chance Insulin icodec is the new medicine being tested while insulin glargine is already approved and can be prescribed by doctors Participants will get one injection of insulin icodec once a week or one injection of insulin glargine once a day depending on the treatment group participants are assigned into Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh upper arm or stomachThe study will last for about 9 months but participants will only be taking the study medicine for 6 months
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 |
|---|---|---|---|
| 2023-506084-34 | OTHER | European Medical Agency EMA | None |
| U1111-1292-6151 | OTHER | None | None |