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.
Males and females aged 18 or older.
Clinical diagnosis of T1D for at least one year.
Use of AID system for at least three months.
Body Mass Index (BMI) ≥ 23 kg/m2.
Use of GLP1-RA within one month of admission.
Use of SGLT2i within two weeks of admission.
Planned or ongoing pregnancy.
Breastfeeding.
Factorial
Intervention Period 1: Semaglutide + Empagliflozin
DrugSemaglutide 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.
Intervention Period 2: Semaglutide + Empagliflozin Placebo
DrugSemaglutide 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.
Intervention Period 3: Semaglutide Placebo + Empagliflozin
DrugSemaglutide 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.
Intervention Period 4: Semaglutide Placebo + Empagliflozin Placebo
DrugSemaglutide 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.
Time-in-Range
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.
Overall Time In Range
Percentage of time (%) spent in ranges of glucose levels : between 3.9 to 10 mmol/L Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.
Optimal Time In Range
Percentage of time (%) spent in ranges of glucose levels : between 3.9 to 7.8 mmol/L Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.
Time In Hypoglycemia
Percentage of time (%) spent in ranges of glucose levels : below 3.9 and 3.0 mmol/L Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.
Time In Mild Hyperglycemia
Percentage of time (%) spent in ranges of glucose levels : above 7.8 mmol/L Nota Bene: Secondary endpoints will be computed for (i) semaglutide and empagliflozin versus placebo, (ii) semaglutide and empagliflozin versus empagliflozin alone, (iii) semaglutide and empagliflozin versus semaglutide alone.
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McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead sponsor
Diabetes Canada
Collaborator
