Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588504
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese Adolescents
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomised Open-label Cross-over Study to Confirm the Clinical Efficacy and Safety of Dasiglucagon Versus Glucagon for the Treatment of Severe Hypoglycaemia in Asian Adults With Type 1 Diabetes T1D Including an Investigation of Dasiglucagon in a Japanese Adolescent Cohort
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be looking to confirm the effect of dasiglucagon when compared with glucagon for treating very low sugar levels in Asian adults with T1D and the effect of dasiglucagon in Japanese adolescents with T1D This study wants to demonstrate that dasiglucagon can raise low blood sugar levels just as well as glucagon Participants will get dasiglucagon and glucagon In which treatment order participants get study medicines dasiglucagon and glucagon is decided by chance Dasiglucagon is a new medicine but doctors can prescribe it in the US as it is approved there Doctors can prescribe glucagon in multiple countries including Japan as an approved medicine The study will last for about 17 weeks Participant cannot be in the study if the study doctor thinks that there are risks for participants health Women cannot take part if pregnant breast-feeding plan to get pregnant during the study period or not using adequate contraceptive methods For man if participant have sex participant and his partner must use an adequate birth control method during the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None