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.
This trial investigates the effects of adding semaglutide and dapagliflozin to insulin therapy in adults with Type 1 Diabetes, aiming to improve glycaemic control while addressing insulin-induced weight gain.
Where it sits
this study against the rest of the semaglutide corpusSummary and findings
This study evaluates 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% and 11.0%. Participants are randomized to receive either triple therapy (semaglutide, dapagliflozin, and insulin) or dual therapy (semaglutide and insulin) over a 26-week period. The study aims to assess changes in HbA1c and safety outcomes.
Abstract
Aims Attaining target glycaemia can be a challenge in Type 1 Diabetes (T1D) due to insulin-induced weight gain. Adjunct therapy with modern glucose-lowering agents developed for type 2 diabetes (T2D) has great potential but may be insufficiently efficacious and carries risks of hypoglycaemia and ketosis. We designed the first Phase 3 clinical trial to assess the efficacy and safety of adding a Glucagon-Like Peptide 1 receptor agonist (GLP-1RA) and a Sodium-Glucose Co-transporter (SGLT2) Inhibitor to insulin therapy in overweight and obese adults with T1D and glycaemia above target (HbA1c 7.5%-11.0% inclusive) (NCT03899402). Materials and methods In Period 1, participants are randomized 2:1 (open label) for 26 weeks to semaglutide and insulin (uptitrated to 1.0 mg weekly) or standard insulin therapy. In Period 2, those randomized to semaglutide and insulin in Period 1 are further randomized (double-blind) for 26 weeks to dapagliflozin (10 mg daily) or placebo, in addition to semaglutide. The primary objective is to compare change in HbA1c on 'triple therapy' (dapagliflozin, semaglutide and insulin) with 'dual therapy' (placebo, semaglutide and insulin). Secondary objectives include comparisons of triple therapy with standard insulin therapy and dual therapy (semaglutide and insulin) with standard insulin therapy. Safety outcomes include hypoglycaemia and ketosis. A sample size recalculation during the trial based on analysis of masked data revised the original recruitment target from 114 to 82 participants. Conclusion The TTT1 trial will provide clinically useful information on combination adjunct therapy in the treatment of T1D.
Background
This paper addresses the clinical question of how a combination therapy of insulin, semaglutide, and dapagliflozin may affect adults with type 1 diabetes. Previous studies have focused on individual components of this therapy, but the combination's effects are less understood. This study is significant as it seeks to explore a novel approach to managing type 1 diabetes.
Methods
The study is designed as a Phase 3 clinical trial involving adults with type 1 diabetes. Specific details regarding the population size, dosing regimen, duration, and outcome measures are not reported in the abstract.
Results
Not reported in abstract.
Interpretation
Due to the lack of reported results, it is not possible to compare this study's findings to prior literature or assess the clinical significance of the proposed therapy. Without specific data, the implications for practice remain unclear.
Key findings
- Not reported in abstract.
Limitations
- Not reported in abstract.