Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04582435
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2020-10-08
Brief Title:
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2023-09
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:
The aim of the study is to improve clinical outcomes for patients with type 2 diabetes by limiting the burden associated with insulin treatment
Participants will get insulin degludec as well as insulin icodec - Insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors
Participants will administer subcutaneous injections of insulin degludec once daily for at least one week 7 injections but this period may be extended up to 8 weeks Thereafter once weekly subcutaneous injections of insulin icodec will follow resulting in a total of at least 8 but not more than 16 subcutaneous injections of icodec
The study will last for about 17-32 weeks Participants will have at least 5 in-house visits where participants will stay at the clinic and 17 outpatient visits with the study doctor
Women cannot take part if pregnant breast-feeding or plan to become pregnant during the study period
Participants will get insulin degludec as well as insulin icodec - Insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors
Participants will administer subcutaneous injections of insulin degludec once daily for at least one week 7 injections but this period may be extended up to 8 weeks Thereafter once weekly subcutaneous injections of insulin icodec will follow resulting in a total of at least 8 but not more than 16 subcutaneous injections of icodec
The study will last for about 17-32 weeks Participants will have at least 5 in-house visits where participants will stay at the clinic and 17 outpatient visits with the study doctor
Women cannot take part if pregnant breast-feeding or plan to become pregnant during the study period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| U1111-1244-4346 | OTHER | None | None |
| 2019-004606-10 | REGISTRY | European Medicines Agency EudraCT | None |