Evaluating the effects of Semaglutide and Empagliflozin with Automated Insulin Delivery on diabetes control in adults with Type 1 Diabetes
Semaglutide And Empagliflozin Combination Therapy Added To Automated Insulin Delivery In Adults With Type 1 Diabetes (SEMPA)
This study is testing if adding two diabetes medications, Semaglutide and Empagliflozin, to automated insulin delivery systems can help adults with Type 1 Diabetes better manage their blood sugar levels.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06894784 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of Semaglutide and Empagliflozin, both individually and in combination, when added to Automated Insulin Delivery (AID) systems for improving time-in-range in adults with Type 1 Diabetes (T1D). The study employs a 2x2 factorial, randomized, placebo-controlled, double-blind, crossover design, allowing participants to receive all treatment combinations. The primary focus is to determine if the combination therapy enhances diabetes control compared to placebo and to evaluate the safety of these medications in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 or older with a clinical diagnosis of Type 1 Diabetes for at least one year who have been using an Automated Insulin Delivery system for a minimum of three months.
Not a fit: Patients who have recently used GLP1-RA or SGLT2i medications, are pregnant or breastfeeding, or have severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve diabetes management and quality of life for patients with Type 1 Diabetes by increasing time-in-range.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in diabetes management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montreal, Quebec
- Research Institute of the McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Dr. Michael Tsoukas — Division of Endocrinology and Metabolism - McGill University Health Center
- Study coordinator: Keddy Moise, BScHS
- Email: keddy.moise@affiliate.mcgill.ca
- Phone: 438-531-6896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.