Now Enrolling: Join the SEMPA Trial for Type 1 Diabetes and AID Systems
The SEMPA clinical trial (NCT06894784) is a Phase 3 crossover study currently recruiting adults with Type 1 Diabetes. The trial evaluates the clinical effect of adding semaglutide and empagliflozin to standard Automated Insulin Delivery (AID) systems on Time-in-Range (TIR). Below are the core details, timelines, and eligibility requirements for the study.
Study Overview
Study Name: SEMPA (Semaglutide and Empagliflozin Combination Therapy Added to Automated Insulin Delivery in Adults with Type 1 Diabetes)
ClinicalTrials.gov ID: NCT06894784
Condition: Type 1 Diabetes (T1D)
Purpose: To evaluate if adding semaglutide, empagliflozin, or both to an Automated Insulin Delivery (AID) system improves Time-in-Range (TIR) compared to using an AID system alone.
Current Status: Recruiting
Timeline: Started April 2025. Estimated completion in January 2027.
Interventions (Treatments Tested)
Participants will be tested with the following medications alongside their personal AID systems:
Semaglutide: Subcutaneous injection, titrated up to 1.0 mg weekly (or matched placebo).
Empagliflozin: Oral tablet, 2.5 mg daily (or matched placebo).
Study Design
Phase: Phase 3
Structure: 2x2 factorial, randomized, double-blind, crossover.
Crossover Mechanism: Participants do not stay in one group. Every participant will cycle through four 4-week intervention periods, meaning they will eventually test all four combinations:
Semaglutide + Empagliflozin
Semaglutide + Placebo
Placebo + Empagliflozin
Placebo + Placebo
Key Eligibility Criteria
Age: 18 years or older.
Diagnosis: Clinical diagnosis of T1D for at least 1 year.
Device Use: Must have been using a commercial AID system for at least 3 months.
BMI: ≥ 23 kg/m².
Exclusions: Recent use of GLP-1 receptor agonists (within 1 month), recent severe hypoglycemia or DKA, or significant kidney/gallbladder issues.
Recruitment Location
Currently, the study lists one primary recruiting location:
Research Institute of the McGill University Health Centre (Montreal, Quebec, Canada)
Contacts: * Keddy Moise (438-531-6896 / keddy.moise@affiliate.mcgill.ca)
Dr. Ahmad Haidar (514-398-4491 / ahmad.haidar@mcgill.ca)
