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
NCT ID: NCT06894784
Last Updated: 2025-03-30
Study Results
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Basic Information
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RECRUITING
PHASE3
36 participants
INTERVENTIONAL
2025-04-30
2027-01-31
Brief Summary
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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.
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Detailed Description
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1. Study Design and Randomization:
Factorial Design: The 2x2 factorial design allows for the simultaneous assessment of two interventions (semaglutide and empagliflozin) and their interaction. This design efficiently explores the individual and combined effects of the drugs. Randomization: Participants will be randomized in a 1:1 ratio to determine the order of the semaglutide and placebo injections (Arm A: semaglutide first, Arm B: placebo first). Within each arm, the order of empagliflozin and placebo tablets will also be randomized 1:1. This ensures that any potential carryover effects are minimized. Double-Blind: Both participants and investigators will be blinded to the treatment assignments, minimizing bias in data collection and analysis. Crossover Design: Each participant will receive all four treatment combinations (semaglutide + empagliflozin, semaglutide + placebo, placebo + empagliflozin, placebo + placebo), allowing for within-subject comparisons and reducing inter-individual variability.
2. Study Procedures:
Screening and Baseline: Participants will undergo a screening visit to confirm eligibility criteria. Baseline characteristics, including demographic data, medical history, and current diabetes management, will be collected. Titration Period (Semaglutide): A 12-week titration period for semaglutide will be implemented to achieve a stable dose and minimize gastrointestinal side effects. This gradual dose escalation will follow standard clinical practice. Intervention Periods (Four Weeks Each): Each participant will undergo four four-week intervention periods, representing the four treatment combinations. During each intervention period, participants will continue to use their AID system.
Participants will receive daily injections (semaglutide or placebo) and daily tablets (empagliflozin or placebo) according to the randomization schedule. Washout Periods: A two to four-week washout period will be implemented between the semaglutide/placebo arms to eliminate any carryover effects of semaglutide. A one to seven-day washout period will be implemented between the empagliflozin/placebo tablet administrations. This short period is considered sufficient for the elimination of empagliflozin. CGM Data Collection:
Continuous glucose monitoring (CGM) data will be collected throughout the study, with a focus on the four-week intervention periods. CGM data will be used to calculate the primary outcome (TIR) and secondary outcomes. Questionnaires: At the end of each four-week intervention period, participants will complete questionnaires to assess: Diabetes distress and treatment satisfaction. Adverse Event Monitoring: Adverse events will be recorded throughout the study, from informed consent to the end of participation.
3. Statistical Analysis:
Intention-to-Treat (ITT) Analysis: Statistical analyses will be performed on an ITT basis, including all participants who were randomized. Factorial Analysis: The factorial design allows for the assessment of the main effects of semaglutide and empagliflozin, as well as their interaction. Mixed-Effects Models: Mixed-effects models will be used to account for repeated measures and within-subject variability. Descriptive Statistics: Descriptive statistics will be used to summarize baseline characteristics and outcome measures. Adverse Event Analysis: Adverse events will be summarized and analyzed for frequency and severity.
4. Safety Considerations:
Participants will be closely monitored for adverse events. Rescue medications will be available for hypoglycemic events. Participants will receive education on the safe use of semaglutide, empagliflozin, and the AID system. The investigators will have the right to remove any participant from the study at any time if they feel it is in the best interest of the participant.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Semaglutide, Ozempic® (at maximum tolerated dose) + Automated Insulin Delivery system
Semaglutide is a Glucagon-Like Peptide 1 Receptor Agonist. It stimulates GLP1 in the body, which allows for increased satiety, reduced glucagon levels, delayed gastric emptying, and in some, increased insulin secretion. It is a once per week subcutaneous injection.
Participants will self-administer the colourless solution subcutaneously in the abdomen, thighs, or upper arms once weekly per the dosing schedule below.
Weeks 1-4 : 0.25 mg (0.19 mL) Weeks 5-8 : 0.50 mg (0.38 mL) Weeks 9-12 : 1.0 mg (0.74 mL) Weeks 13-22 : 1.0 mg (0.74 mL)
To match the recommendation from the product monograph and to ensure a steady state is reached before initiating the evaluation period, study drugs will be titrated for 12 weeks.
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.
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.
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.
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.
Placebo + Automated Insulin Delivery system
Participants will self-administer the colourless solution subcutaneously in the abdomen, thighs, or upper arms once weekly per the dosing schedule below.
Weeks 1-4 : 0.19 mL Weeks 5-8 : 0.38 mL Weeks 9-12 : 0.74 mL Weeks 13-22 : 0.74 mL
To match the recommendation from the product monograph and to ensure a steady state is reached before initiating the evaluation period, study drugs will be titrated for 12 weeks.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Diabetes Canada
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Michael Tsoukas
Assistant Professor of Medicine, Principal Investigator
Principal Investigators
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Dr. Michael Tsoukas
Role: PRINCIPAL_INVESTIGATOR
Division of Endocrinology and Metabolism - McGill University Health Center
Dr. Melissa-Rosina Pasqua
Role: STUDY_DIRECTOR
Division of Endocrinology and Metabolism - McGill University Health Center
Dr. Vanessa Tardio
Role: STUDY_DIRECTOR
Division of Endocrinology and Metabolism - McGill University Health Center
Dr. Ahmad Haidar
Role: STUDY_DIRECTOR
Department of Biomedical Engineering - McGill University
Locations
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Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Pasqua MR, Jafar A, Kobayati A, Tsoukas MA, Haidar A. Low-Dose Empagliflozin as Adjunct to Hybrid Closed-Loop Insulin Therapy in Adults With Suboptimally Controlled Type 1 Diabetes: A Randomized Crossover Controlled Trial. Diabetes Care. 2023 Jan 1;46(1):165-172. doi: 10.2337/dc22-0490.
Haidar A, Yale JF, Lovblom LE, Cardinez N, Orszag A, Falappa CM, Gouchie-Provencher N, Tsoukas MA, El Fathi A, Rene J, Eldelekli D, Lanctot SO, Scarr D, Perkins BA. Reducing the need for carbohydrate counting in type 1 diabetes using closed-loop automated insulin delivery (artificial pancreas) and empagliflozin: A randomized, controlled, non-inferiority, crossover pilot trial. Diabetes Obes Metab. 2021 Jun;23(6):1272-1281. doi: 10.1111/dom.14335. Epub 2021 Feb 28.
Rosenstock J, Marquard J, Laffel LM, Neubacher D, Kaspers S, Cherney DZ, Zinman B, Skyler JS, George J, Soleymanlou N, Perkins BA. Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials. Diabetes Care. 2018 Dec;41(12):2560-2569. doi: 10.2337/dc18-1749. Epub 2018 Oct 4.
Tsoukas MA, Woo V, Tobe SW, Slee A, Rapattoni W, Ang FG, Seufert J, Neuen BL, Arnott C, Mahaffey KW, Wheeler DC. Cardiovascular and kidney outcomes with canagliflozin according to type 2 diabetes treatment targets at baseline: Data from the CANVAS programme and CREDENCE. Diabetes Obes Metab. 2023 Jul;25(7):2038-2042. doi: 10.1111/dom.15057. Epub 2023 Apr 4. No abstract available.
Riddle MC, Cefalu WT. SGLT Inhibitors for Type 1 Diabetes: An Obvious Choice or Too Good to Be True? Diabetes Care. 2018 Dec;41(12):2444-2447. doi: 10.2337/dci18-0041. No abstract available.
Pradhan A, Vohra S, Vishwakarma P, Sethi R. Review on sodium-glucose cotransporter 2 inhibitor (SGLT2i) in diabetes mellitus and heart failure. J Family Med Prim Care. 2019 Jun;8(6):1855-1862. doi: 10.4103/jfmpc.jfmpc_232_19.
Related Links
Access external resources that provide additional context or updates about the study.
Sizar O, Podder V, Talati R. Empagliflozin. In: StatPearls. StatPearls Publishing; 2024. Accessed April 15, 2024
Ozempic® Side Effects \| Ozempic® (semaglutide) injection. Accessed April 15, 2024
Other Identifiers
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2025-10723
Identifier Type: -
Identifier Source: org_study_id
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