What is this trial studying for Type 1 Diabetes?

This trial is studying how the drugs Semaglutide and Empagliflozin, alone or combined, affect blood sugar control in adults using Automated Insulin Delivery systems. The researchers want to see if these drugs increase the amount of time blood sugar stays within a target range. The study is sponsored by McGill University Health Centre.

Who may be eligible for this Type 1 Diabetes clinical trial?

Adults aged 18 or older with a diagnosis of Type 1 Diabetes for at least one year who have been using an Automated Insulin Delivery system for at least three months may be eligible. Both males and females can join. Important disqualifying factors include recent use of similar diabetes drugs, pregnancy, or certain medical conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this Type 1 Diabetes clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06894784

Semaglutide and Empagliflozin Combination Therapy Added to Automated Insulin Delivery in Adults with Type 1 Diabetes

Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2025-03-30

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating if the drugs Empagliflozin and Semaglutide, alone or combined, can improve blood sugar control by increasing time-in-range in adults with Type 1 Diabetes who use Automated Insulin Delivery AID systems. This study also monitors the safety of these drugs in this setting. It is a randomized, double-blind, placebo-controlled Phase 3 crossover trial designed to compare the effects of these treatments in the same participants. Participants will receive four different treatment combinations through a crossover design semaglutide injection plus empagliflozin tablet, semaglutide injection plus placebo tablet, placebo injection plus empagliflozin tablet, and placebo injection plus placebo tablet. Semaglutide is given by weekly subcutaneous injection with a 12-week dose escalation period to reach a stable dose. Empagliflozin or its placebo is taken daily by tablet. Washout periods between treatments help avoid carryover effects. During the study, participants will use their personal AID systems continuously while researchers collect continuous glucose monitoring data to measure time-in-range and other blood sugar outcomes. Questionnaires will assess diabetes distress and treatment satisfaction after each intervention period. Safety is closely monitored throughout, including tracking adverse events and providing rescue medications for low blood sugar. The entire participation involves multiple treatment periods with careful monitoring and data collection.

CONDITIONS

Brief 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

Age: 18Years +

All Genders

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) of 23 kg/m2 or higher

You will not qualify if you...

Use of GLP1 receptor agonists 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 less than 30 mL/min/1.73 m2 within four months before enrollment
Significant diabetic retinopathy or gastroparesis as judged by the investigator
Bariatric surgery within six months before enrollment
Serious medical or psychiatric illness interfering with participation
Inability or unwillingness to follow safe diabetes management practices as judged by the investigator

Research Team

Keddy Moise, BScHS

Dr. Ahmad Haidar

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