RECRUITINGPhase 3INTERVENTIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

The inclusion criteria at the time of enrollment are: - 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. The exclusion criteria are: - Use of GLP1-RA within one month of admission. - Use of SGLT2i within two weeks of admission. - Planned or ongoing pregnancy. - Breastfeeding. - Severe hypoglycemic episode within three months of admission (defined as an event where blood glucose levels were \< 4.0 mmol/L, resulting in seizure, loss of consciousness, or the need to present to the emergency department). - Diabetic ketoacidosis episode within six months of admission. - History of acute pancreatitis, chronic pancreatitis, or gallbladder disease. - Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2. - Severe impairment of renal function with an eGFR \< 30 mL/min/1.73 m2 within four months of admission. eGFR will be computed using the CKD-EPI method. - Clinically significant diabetic retinopathy or gastroparesis, as per the investigator's judgement. - Bariatric surgery within six months of admission. - A serious medical or psychiatric illness that would likely interfere with participation in this study, as per the investigator's judgement. - Inability or unwillingness to comply with safe diabetes management practices, as per the investigator's judgment. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

The inclusion criteria at the time of enrollment are: * 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. The exclusion criteria are: * Use of GLP1-RA within one month of admission. * Use of SGLT2i within two weeks of admission. * Planned or ongoing pregnancy. * Breastfeeding. * Severe hypoglycemic episode within three months of admission (defined as an event where blood glucose levels were \< 4.0 mmol/L, resulting in seizure, loss of consciousness, or the need to present to the emergency department). * Diabetic ketoacidosis episode within six months of admission. * History of acute pancreatitis, chronic pancreatitis, or gallbladder disease. * Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2. * Severe impairment of renal function with an eGFR \< 30 mL/min/1.73 m2 within four months of admission. eGFR will be computed using the CKD-EPI method. * Clinically significant diabetic retinopathy or gastroparesis, as per the investigator's judgement. * Bariatric surgery within six months of admission. * A serious medical or psychiatric illness that would likely interfere with participation in this study, as per the investigator's judgement. * Inability or unwillingness to comply with safe diabetes management practices, as per the investigator's judgment.

Treatments Being Tested

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.

Locations (1)

Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada