NCT06894784RecruitingPhase 3
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
Semaglutide And Empagliflozin Combination Therapy Added To Automated Insulin Delivery In Adults With Type 1 Diabetes (SEMPA)
Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. The primary hypothesis of this study is : \- The combination therapy of semaglutide and empagliflozin will increase time-in-range compared to placebo when added to AID therapy. The secondary hypotheses are : * The combination therapy of semaglutide and empagliflozin will increase time-in-range compared to semaglutide alone when added to AID therapy. * The combination of semaglutide and empagliflozin will increase time-in-range compared to empagliflozin alone when added to AID therapy. In this study, the research team will compare Empagliflozin and Semaglutide to a placebo (a look-alike substance that contains no drug) to see if they improve time-in-range. This study has four groups: Group 1: semaglutide injection + empagliflozin tablet. Group 2: semaglutide injection + placebo tablet. Group 3: placebo injection + empagliflozin tablet. Group 4: placebo injection + placebo tablet. This is a 2x2 factorial crossover study. This means that all participants will undergo both injection intervention (placebo and semaglutide) arms. Within each injection arm, participants will take both tablets (placebo and empagliflozin). By the end of the study, every participant will have taken part in each study group.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 7 Mar 2025
- Start date
- Apr 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Diseases
- Type 1 diabetes
- NCT number
- NCT06894784
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 36
- From Apr 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Institute of the McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.