Status:
RECRUITING
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
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Diabetes Canada
Conditions:
Diabetes Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This study is designed as a 2x2 factorial, randomized, placebo-controlled, double-blind, crossover trial to investigate the effects of semaglutide and empagliflozin, individually and combined, on time...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06894784
Start Date
April 1 2025
End Date
January 1 2027
Last Update
March 30 2025
Active Locations (1)
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1
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1