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
Study context
- Population
- Overweight and obese adults with T1D and HbA1c 7.5%-11.0% inclusiverevised recruitment target
- Participants
- 82 participants
- Planned comparison
- Triple therapy vs dual therapy
- Primary endpoint
- Change in HbA1c, triple therapy vs dual therapy
Methodological detailsdesign and methods paper, international, phase 3, two-period, open label (Period 1), double-blind (Period 2), placebo-controlled (Period 2), sample size recalculation, Safety outcomes include hypoglycaemia and ketosis, Period 1: randomized 2:1 (open label) for 26 weeks to semaglutide and insulin (uptitrated to 1.0 mg weekly) or standard insulin therapy, Period 2: semaglutide and insulin participants further randomized (double-blind) for 26 weeks to dapagliflozin (10 mg daily) or placebo, in addition to semaglutide, Secondary objectives: triple therapy vs standard insulin therapy and dual therapy vs standard insulin therapy, Sample size recalculation based on masked data revised recruitment target from 114 to 82 participants
- Design and methods paper
- International
- Phase 3
- Two-period
- Open label (Period 1)
- Double-blind (Period 2)
- Placebo-controlled (Period 2)
- Sample size recalculation
- Safety outcomes include hypoglycaemia and ketosis
- Period 1: randomized 2:1 (open label) for 26 weeks to semaglutide and insulin (uptitrated to 1.0 mg weekly) or standard insulin therapy
- Period 2: semaglutide and insulin participants further randomized (double-blind) for 26 weeks to dapagliflozin (10 mg daily) or placebo, in addition to semaglutide
- Secondary objectives: triple therapy vs standard insulin therapy and dual therapy vs standard insulin therapy
- Sample size recalculation based on masked data revised recruitment target from 114 to 82 participants
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
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. Diabetes Obes Metab. Published 19 July 2026. doi:10.
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