Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04569994
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2020-09-24
Brief Title:
A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Trial Investigating the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Healthy Subjects and in Subjects With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2023-06
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 is investigating the safety and tolerability of the new investigational product NNC0363-0845 its concentrations in the blood and its effect on the blood sugar for the treatment of diabetes The study consists of 3 parts The first part of the study is conducted in healthy people while the second part involves people with type 1 diabetes T1D Part 3 of this trial involves also people with T1D
The study will test how NNC0363-0845 is tolerated by the body how it is taken up in the blood how long it stays there and how much the blood sugar is lowered Healthy volunteers will either get NNC0363-0845 or placebo - which treatment is decided by chance Participants with type 1 diabetes will either get NNC0363-0845 or insulin degludec Tresiba also decided by chance It is the first time that NNC0363-0845 is tested in humans Participants will get one dose of NNC0363-0845 or placebo or insulin degludec injected into their left thigh Participation in the study will last for up to 6 weeks There will be one Informed Consent visit and 6 clinic visits with the study doctor Healthy volunteers will have blood sampling to measure blood sugar and the concentration of the investigational product in the blood Participants with type 1 diabetes will have a clamp experiment where the blood sugar is measured and controlled for up to 42 hours
For Part 3 the total duration of the trial for each individual is expected to be approximately 3-9 weeks
Participants cannot be in the study if the study doctor thinks that there are risks for their health Women can only take part in the study if they are of non-child bearing potential
The study will test how NNC0363-0845 is tolerated by the body how it is taken up in the blood how long it stays there and how much the blood sugar is lowered Healthy volunteers will either get NNC0363-0845 or placebo - which treatment is decided by chance Participants with type 1 diabetes will either get NNC0363-0845 or insulin degludec Tresiba also decided by chance It is the first time that NNC0363-0845 is tested in humans Participants will get one dose of NNC0363-0845 or placebo or insulin degludec injected into their left thigh Participation in the study will last for up to 6 weeks There will be one Informed Consent visit and 6 clinic visits with the study doctor Healthy volunteers will have blood sampling to measure blood sugar and the concentration of the investigational product in the blood Participants with type 1 diabetes will have a clamp experiment where the blood sugar is measured and controlled for up to 42 hours
For Part 3 the total duration of the trial for each individual is expected to be approximately 3-9 weeks
Participants cannot be in the study if the study doctor thinks that there are risks for their health Women can only take part in the study if they are of non-child bearing potential
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 |
|---|---|---|---|
| 2019-004658-27 | REGISTRY | European Medicines Agency EudraCT | None |
| U1111-1244-4315 | OTHER | None | None |