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New treatment option for Diabetes Type 1
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 Intervention Period 1: Semaglutide + Empagliflozin?
Intervention Period 1: Semaglutide + Empagliflozin is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for diabetes type 1.
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 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.
- 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
- The 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
You likely can't join if
- 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...
See the full eligibility criteria
- The 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
- 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...
- 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's taking place
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.