Insulin, Semaglutide and Dapagliflozin in Adults With Type 1 Diabetes: Design and Methods of Triple Therapy for Type 1 Diabetes (TTT1)-An International Phase 3 Clinical Trial.
Joseph G Timmons, Husam Ghanim, James G Boyle et al.
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In 30 seconds
The TTT1 trial is a Phase 3 randomized controlled trial assessing the efficacy and safety of adding semaglutide and dapagliflozin to insulin therapy in overweight and obese adults with Type 1 Diabetes (T1D) and HbA1c levels between 7.5%-11.0%. The study aims to evaluate changes in HbA1c with triple therapy compared to dual therapy.
Key findings
- Participants are randomized 2:1 for 26 weeks to semaglutide and insulin or standard insulin therapy.
- In Period 2, those on semaglutide will be further randomized to dapagliflozin or placebo for an additional 26 weeks.
- The primary objective is to compare change in HbA1c between triple therapy and dual therapy.
Why it matters
This trial explores innovative adjunct therapies for managing T1D, addressing challenges like insulin-induced weight gain and suboptimal glycaemic control, which are critical for improving patient outcomes.