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
- Status
- RecruitingResults none
- Why it is watched
- population of special interest (non-obese / healthy / non-diabetic)
- Who it enrolls
- age 18 Years to no upper limit; BMI ≥23 required; non-obese participants included; conditions: Diabetes Type 1
- Interventions
- Intervention Period 1: Semaglutide + Empagliflozin; Intervention Period 2: Semaglutide + Empagliflozin Placebo; Intervention Period 3: Semaglutide Placebo + Empagliflozin; Intervention Period 4: Semaglutide Placebo + Empagliflozin Placebo
- Conditions
- Diabetes Type 1
- Phase and size
- Phase 3 · 36 participants
- Dates
- Start 2025-04
Primary completion 2027-01 - Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Time-in-RangeAt days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.