NCT06894784View on ClinicalTrials.gov

A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes

PHASE3RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2027

Conditions
Diabetes Type 1
Interventions
DRUG

Intervention Period 1: Semaglutide + Empagliflozin

"Semaglutide Injection: Subcutaneous injection, titrated over 12 weeks to a stable dose (1 mg), administered weekly.~Empagliflozin Tablet: Oral tablet (2.5 mg), administered daily.~Automated Insulin Delivery (AID) System: Continuous use of the participant's personal commercial AID system."

DRUG

Intervention Period 2: Semaglutide + Empagliflozin Placebo

"Semaglutide Injection: Subcutaneous injection, titrated over 12 weeks to a stable dose (1 mg), administered weekly.~Empagliflozin Placebo Tablet: Oral placebo tablet, matched in appearance to empagliflozin (2.5 mg), administered daily.~Automated Insulin Delivery (AID) System: Continuous use of the participant's personal commercial AID system."

DRUG

Intervention Period 3: Semaglutide Placebo + Empagliflozin

"Semaglutide Placebo Injection: Subcutaneous placebo injection (titrated over 12 weeks to a stable 1 mg dose), matched in appearance to semaglutide, administered weekly.~Empagliflozin Tablet: Oral tablet (2.5 mg), administered daily.~Automated Insulin Delivery (AID) System: Continuous use of the participant's personal commercial AID system."

DRUG

Intervention Period 4: Semaglutide Placebo + Empagliflozin Placebo

"Semaglutide Placebo Injection: Subcutaneous placebo injection (titrated over 12 weeks to a stable 1 mg dose), matched in appearance to semaglutide, administered weekly.~Empagliflozin Placebo Tablet: Oral placebo tablet (2.5 mg), matched in appearance to empagliflozin, administered daily.~Automated Insulin Delivery (AID) System: Continuous use of the participant's personal commercial AID system."

Trial Locations (1)

H4A 3J1

RECRUITING

Research Institute of the McGill University Health Centre, Montreal

All Listed Sponsors
collaborator

Diabetes Canada

OTHER

lead

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

OTHER