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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

RecruitingPhase 3Ages 18 Years - anyAllMcGill University Health Centre/Research Institut…
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In plain words

What the trial is, and whether it could suit you

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 su

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📋 Eligibility rules (as published)
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.
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What it tests

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

1 site
Research Institute of the McGill University Health Centre
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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