Table 1.
VERTIS study name | MONO [24, 26] | MET [23, 27] | SITA2 [18] | SU [20, 28] | RENAL [19] | SITA [21] | FACTORIAL [22] |
---|---|---|---|---|---|---|---|
Clinicaltrials.gov identifier | NCT01958671 | NCT02033889 | NCT02036515 | NCT01999218 | NCT01986855 | NCT02226003 | NCT02099110 |
Number of patients randomized | N = 461 | N = 621 | N = 464 | N = 1326 | N = 468 | N = 291 | N = 1233 |
HbA1c inclusion criterion | 7.0–10.5% | 7.0–10.5% | 7.0–10.5% | 7.0–9.0% | 7.0–10.5% | 8.0–10.5% | 7.5–11.0% |
Background therapy | Diet and exercise | Metformin | Metformin and sitagliptin | Metformin | Diet/exercise with or without AHA | Diet and exercise | Metformin |
Ertugliflozin treatment groups |
Ertugliflozin 5 mg Ertugliflozin 15 mg |
Ertugliflozin 5 mg Ertugliflozin 15 mg |
Ertugliflozin 5 mg Ertugliflozin 15 mg |
Ertugliflozin 5 mg Ertugliflozin 15 mg |
Ertugliflozin 5 mg Ertugliflozin 15 mg |
Ertugliflozin 5 mg + sitagliptin 100 mg Ertugliflozin 15 mg + sitagliptin 100 mg |
Ertugliflozin 5 mg, Ertugliflozin 15 mg, each with and without sitagliptin 100 mg |
Comparator | Placebo | Placebo | Placebo | Glimepiride | Placebo | Placebo | Sitagliptin |
Duration | 26 weeks + 26-week extension | 26 weeks + 78-week extension | 26 weeks + 26-week extension | 52 weeks + 52-week extension | 26 weeks + 26-week extension | 26 weeks | 26 weeks + 26-week extension |
Table was adapted from Fig. 1 in Liu et al. [29]
AHA Antihyperglycemic agent, HbA1c glycated hemoglobin