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Semaglutide

Ozempic, Rybelsus, Wegovy

Quick Stats
Studies 78
Trials 100
Completed PHASE2, PHASE3 INTERVENTIONAL NCT05205928

Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: Outpatient therapy: 11 weeks of drug therapy with usual treatment + 4 weeks of closed-loop therapy
Type: DRUG
Description: The blinded drug will be used with participant's routine therapy (+ continuous glucose monitoring if not already in use) for 11 weeks with follow-up from qualified research personnel concerning pump settings, side effects, and incremental dose increase. While continuing to use the medication, there are 4 weeks of closed-loop pump therapy and drug use; glycemic outcomes will be taken from the last 4 weeks. This will be followed by laboratory and anthropometric testing, followed by 2 weeks of wash-out.

Primary Outcomes

Measure: Percentage of time of plasma glucose levels spent in target range (semaglutide vs placebo)
TimeFrame: 4 weeks
Description: Target range is defined to be between 3.9 and 10.0 mmol/L of placebo on closed-loop system vs semaglutide (at maximal tolerated dose) on closed-loop insulin system.

Trial Information

NCT ID

NCT05205928

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2, PHASE3

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last Updated

December 15, 2025