LivingGLP1
Study S000181

Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care: a Double-blind, Cross-over, Randomized Controlled Trial

Included trial: extracted dataClinicalTrials.gov recordStudy Protocol and Statistical Analysis Plan (PDF)

Registration

Registration
NCT05205928
Acronym
SEMA-AP
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE2; PHASE3
Masking
TRIPLE
Status
COMPLETED
Enrollment
28
Start
2022-10-02
Primary completion
2024-04-15
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions
Type 1 Diabetes; Diabetes Mellitus, Type 1
Interventions
DRUG:Outpatient therapy: 11 weeks of drug therapy with usual treatment + 4 weeks of closed-loop therapy
Results posted
FALSE
Individual participant data sharing
YES

Registered primary outcomes

  • Percentage of time of plasma glucose levels spent in target range (semaglutide vs placebo) [4 weeks]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0017835Subcutaneous weekly semaglutide with automated insulin delivery in type 1 diabetes: a double-blind, randomized, crossover trial.
Pasqua MR, Nature medicine
2025Randomized trialPMID 39794615DOIcites ClinicalTrials.gov:NCT05205928; registry reference DERIVED:39794615
R0045884Cardiovascular Risk Prediction Modelling with Semaglutide in Patients with Type 1 Diabetes
Massimo Nardone, Journal of the American Society of Nephrology
2025Randomized trialDOIcites ClinicalTrials.gov:NCT05205928
R0046280798-P: Semaglutide Effect during Mixed-Meal Tolerance Test (MMTT) with Fully Closed-Loop Therapy in Type 1 Diabetes (T1D)
Melissa‐Rosina Pasqua, Diabetes
2025Randomized trialDOIcites ClinicalTrials.gov:NCT05205928