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

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether two medications, Semaglutide and Empagliflozin, can help adults with Type 1 Diabetes better control their blood sugar levels when used alongside an Automated Insulin Delivery (AID) system. The main goal is to see if using these medications together improves the amount of time that patients spend within their target blood sugar range compared to a placebo, which is a dummy treatment that contains no active drugs. The study will also look at how safe these medications are for participants.

To be eligible for this trial, participants need to be at least 18 years old and have been diagnosed with Type 1 Diabetes for at least a year. They should also have used an AID system for the past three months and have a body mass index (BMI) of 23 or higher. Participants will be randomly assigned to one of four groups, receiving different combinations of the medications and placebos over the course of the study. This design allows everyone to experience each treatment, helping researchers gather valuable information about the effectiveness and safety of the medications. Overall, this study aims to find better ways to manage diabetes and improve daily life for those living with this condition.

Gender

ALL

Eligibility 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.