Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288412
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-02-23
Brief Title:
A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
Pharmacodynamic Properties of Insulin Icodec During Exercise and Prolonged Fasting in Participants With Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-03
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 study will investigate the safety of once weekly insulin icodec subcutaenously sc during and after exercise and prolonged fasting in patients with type 2 diabetes T2D Participants will first receive insulin decludec Tresiba a long-acting insulin taken once daily for atleast one week Afterwards participants will receive insulin icodec that will be administered once weekly at the study site for a minimum of 7 weeks and maximum of 14 weeks Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes The study will last for about 16-30 weeks Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days Female participant cannot take part if she is pregnant breast-feeding or planning to become 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 |
|---|---|---|---|
| 2023-505012-38 | OTHER | European Medical Agency EMA | None |
| U1111-1285-1665 | OTHER | None | None |