Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care
Status:
Not yet recruiting
Trial end date:
2024-12-30
Target enrollment:
Participant gender:
Summary
A closed-loop insulin system, also referred to as the "artificial pancreas" (AP), is made up
of an insulin pump, a continuous glucose monitor, and an application communicating between
the two to adjust insulin administration based on glucose control. This is meant for the
treatment of type 1 diabetes. The McGill Artificial Pancreas (MAP) has been used previously
in type 1 diabetes with significant benefits. Though prior studies have shown significant
benefit with this system, some challenges still exist.
Semaglutide is used in type 2 diabetes and obesity; it is a once-weekly injectable medication
that increases levels of a gut hormone called Glucagon-Like Peptide-1, which modifies gastric
emptying, suppresses glucagon, and suppresses appetite. Though its use is not approved in
type 1 diabetes in North America, it (along with similar drugs) has been used in studies as
adjunctive therapy with insulin with benefits on blood sugar control. Similar medications
have been used in type 1 diabetes (such as liraglutide and exenatide), but are not as strong
in glucose effect even in type 2 diabetes as compared with semaglutide.
The purpose of our study is to see if semaglutide administered weekly at the maximum
tolerated dose in those with type 1 diabetes will have improved glucose control (as per time
in target range from continuous glucose monitoring data) compared to placebo, while using a
closed-loop insulin system.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre