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

Summary

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.

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.

Sponsors & Collaborators

• Diabetes Canada

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• Dr. Michael Tsoukas · Division of Endocrinology and Metabolism - McGill University Health Center

• Dr. Melissa-Rosina Pasqua · Division of Endocrinology and Metabolism - McGill University Health Center

• Dr. Vanessa Tardio · Division of Endocrinology and Metabolism - McGill University Health Center

• Dr. Ahmad Haidar · Department of Biomedical Engineering - McGill University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-30

Primary Completion

2027-01-31

Completion

2027-01-31

FDA Drug

Yes

Countries

• Canada

Study Locations