Diabetes Type 1 study: Intervention Period
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
ClinicalTrials.gov ID: NCT06894784
What this study is testing
What is Semaglutide + Empagliflozin?
An investigational combination of a once‑weekly injectable medicine and a daily oral tablet being studied for adults with Type 1 Diabetes. Semaglutide is designed to mimic a gut hormone that helps regulate blood sugar, and empagliflozin is designed to help the kidneys remove glucose from the body.
Also referred to as Semaglutide, Empagliflozin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see whether adding semaglutide and empagliflozin, alone or together, improves the amount of time patients’ blood sugar stays in the target range and whether the drugs are safe with automated insulin delivery.
- Who it's for
- Adults with type 1 diabetes who use automated insulin delivery systems.
- What's involved
- Participants will receive injections (semaglutide or a placebo) and tablets (empagliflozin or a placebo) in a 2×2 crossover design, meaning everyone will try all four combinations over the course of the study.
- Time commitment
- The trial lasts several months; participants will have multiple clinic visits and will take injections and tablets during each phase of the study.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Diabetic ketoacidosis episode within six months of admission.
See the full eligibility criteria
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.