Table 1.
Summary of trial design, duration, primary and secondary endpoints and participant baseline characteristics in currently available literature on Phase III studies involving SGLT inhibitor adjunct therapy in type 1 diabetes
| Study detail | Dapagliflozin | Sotagliflozin | ||
|---|---|---|---|---|
| Study name | DEPICT-1 | InTandem1 | InTandem2 | InTandem3 |
| Design | Optimise diabetes management | Optimise insulin | Optimise insulin | Standard of care insulin |
| Study arms | Three (PBO, DAPA 5 mg, DAPA 10 mg) | Three (PBO, SOTA 200 mg, SOTA 400 mg) | As for inTandem1 | Two (PBO, SOTA 400 mg) |
| Total N | 833 | 793 | 782 | 1402 |
| Study duration | 52 weeksa | 52 weeksa | 52 weeksa | 24 weeks |
| Primary endpoint | HbA1c change from baseline at week 24 | Reduction in HbA1c vs PBO on optimised insulin (24 weeks) | As for inTandem1 | Proportion with HbA1c <53 mmol/mol (<7.0%) no SH and no DKA (24 weeks) |
| Secondary key endpoints | Proportion with HbA1c decrease of ≥6 mmol/mol (≥0.5%) without SH at 24 weeks; % change in total daily insulin; % change in body weight; CGM change in mean 24 h glucose, MAG, % 24 h readings within target range | Proportion with HbA1c <53 mmol/mol (<7.0%), no SH, and no DKA; body weight, bolus insulin dose, FPG, DTSQ, DDS2 | As for inTandem1 | HbA1c, body weight, SBP, bolus insulin dose |
| Mean age of participants | 42 years | 46 years | 41 years | 42 years |
| Mean duration of type 1 diabetes | 20 years | 24 years | 18 years | 20 years |
| Method of insulin delivery | 40% CSII; 60% MDI | 60% CSII; 40% MDI | 26% CSII; 74% MDI | 40% CSII; 60% MDI |
| Mean BMI at baseline | 28 kg/m2 | 30 kg/m2 | 28 kg/m2 | 28 kg/m2 |
| Mean HbA1c at screening | 73 mmol/mol (8.8%) | 66 mmol/mol (8.2%) | 68 mmol/mol (8.4%) | 68 mmol/mol (8.4%) |
| Mean HbA1c at baseline | 69 mmol/mol (8.5%; after 8 weeks’ lead-in) | 60 mmol/mol (7.6%; after 6 weeks’ optimisation) | 61 mmol/mol (7.7%; after 6 weeks’ optimisation) | 66 mmol/mol (8.2%) |
| Mean baseline SBP | Not reported | 120 mmHg | 123 mmHg | 122 mmHg |
| eGFR inclusion criteria | Not reported | ≥45 ml min−1 [1.73 m]−2 | ≥45 ml min−1 [1.73 m]−2 | ≥45 ml min−1 [1.73 m]−2 |
These are not head-to-head studies
aThis table shows 24 week data from DEPICT, inTandem1 and inTandem2
CSII, Continuous subcutaneous insulin infusion (pump); DAPA, dapagliflozin; DDS2, Diabetes Distress Scale 2; DTSQ, Diabetes Treatment Satisfaction Questionnaire; FPG, fasting plasma glucose; MAG, mean absolute glucose change; PBO, placebo; SH, severe hypoglycaemia; SOTA, sotagliflozin