Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-29 @ 5:49 PM
Study NCT ID:
NCT04712266
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2021-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
Sponsor:
Abvance Therapeutics
Organization:
Study Overview
Official Title:
A Randomized, Double-blinded Trial to Investigate Glycemic Excursions Following an Oral Mixed Meal Challenge in Subjects With Type 1 Diabetes When Concomitantly Treated With Insulin Alone or Co-administered Insulin and Glucagon
Status:
COMPLETED
Status Verified Date:
2021-01
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 is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.
Detailed Description:
Subjects were be studied on two occasions, in randomized sequence, whereby glycemic excursions are assessed following an oral mixed meal challenge while treated with either insulin alone or co-administered insulin and glucagon.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: