drugset / Trial / NCT06021145
Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes
Phase 4
Recruiting
46 enrolled
McGill University Health Centre/Research Institute of the McGill University Health Centre
Diabetes Canada · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this 26-week multicenter, randomized, parallel, placebo-controlled trial is to test the effectiveness of empagliflozin use in conjunction with automated insulin delivery (AID) to improve glucose control in individuals with type 1 diabetes who do not meet target recommendations for time in range (3.9-10.0 mmol/L). The main question it aims to answer is: \- Will use of empagliflozin (2.5 mg/day) increase time spent in the target range of 3.9 to 10.0 mmol/L compared to placebo for individuals on an AID system who do not meet glycemic targets? Participants will either take 2.5 mg of empagliflozin or a placebo daily for 26 weeks while remaining on their current AID system.
Timeline
- Start
- 2024-04-02
- Primary completion
- 2025-05
- Completion
- 2025-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 2.5 mg | Oral |