Actively 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
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2025-03-30
36
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
D
Diabetes Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 or older.
- Clinical diagnosis of Type 1 Diabetes for at least one year.
- Use of Automated Insulin Delivery system for at least three months.
- Body Mass Index (BMI) 23 kg/m2 or higher.
You will not qualify if you...
- Use of GLP1-RA medications within one month before enrollment.
- Use of SGLT2 inhibitors within two weeks before enrollment.
- Planned or ongoing pregnancy.
- Breastfeeding.
- Severe hypoglycemic episode within three months before enrollment.
- Diabetic ketoacidosis episode within six months before enrollment.
- History of acute or chronic pancreatitis or gallbladder disease.
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.
- Severe kidney impairment with eGFR below 30 mL/min/1.73 m2 within four months before enrollment.
- Clinically significant diabetic retinopathy or gastroparesis.
- Bariatric surgery within six months before enrollment.
- Serious medical or psychiatric illness likely to interfere with study participation.
- Inability or unwillingness to follow safe diabetes management practices.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
K
Keddy Moise, BScHS
CONTACT
D
Dr. Ahmad Haidar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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