Semaglutide And Empagliflozin Combination Therapy Added To Automated Insulin Delivery In Adults With Type 1 Diabetes (SEMPA)

NCT06894784 Phase 3 RECRUITING

The goal of this clinical trial is to learn if Empagliflozin and Semaglutide, individually and combined, added to Automated Insulin Delivery (AID) works to improve time-in-range in adults living with Type 1 Diabetes. It will also evaluate the safety of Empagliflozin and Semaglutide in this context. The primary hypothesis of this study is : \- The combination therapy of semaglutide and empagliflozin will increase time-in-range compared to placebo when added to AID therapy. The secondary hypotheses are : * The combination therapy of semaglutide and empagliflozin will increase time-in-range compared to semaglutide alone when added to AID therapy. * The combination of semaglutide and empagliflozin will increase time-in-range compared to empagliflozin alone when added to AID therapy. In this study, the research team will compare Empagliflozin and Semaglutide to a placebo (a look-alike substance that contains no drug) to see if they improve time-in-range. This study has four groups: Group 1: semaglutide injection + empagliflozin tablet. Group 2: semaglutide injection + placebo tablet. Group 3: placebo injection + empagliflozin tablet. Group 4: placebo injection + placebo tablet. This is a 2x2 factorial crossover study. This means that all participants will undergo both injection intervention (placebo and semaglutide) arms. Within each injection arm, participants will take both tablets (placebo and empagliflozin). By the end of the study, every participant will have taken part in each study group.

Details

Lead sponsor	McGill University Health Centre/Research Institute of the McGill University Health Centre
Phase	Phase 3
Status	RECRUITING
Enrolment	36
Start date	2025-04
Completion	2027-01

Conditions

• Diabetes Type 1

Interventions

• Intervention Period 1: Semaglutide + Empagliflozin
• Intervention Period 2: Semaglutide + Empagliflozin Placebo
• Intervention Period 3: Semaglutide Placebo + Empagliflozin
• Intervention Period 4: Semaglutide Placebo + Empagliflozin Placebo

Primary outcomes

• Time-in-Range — At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.
  The percentage of time spent in target glucose range (3.9-10.0 mmol/L), between Semaglutide and Empagliflozin versus placebo, added to AID therapy.

Countries

Canada