Table 1.
| Trial | N | Patient population | Follow-up mean (wk) | Primary outcome (doses in mg strength) | Other glycemic outcomes (doses in mg strength) |
|---|---|---|---|---|---|
| VERTIS MONO19 (NCT01958671) | 461 | T2D uncontrolled with diet and exercise alone | 52 (26 P run in followed by 26 A control) | A1C change: −0.79% (E5) versus 0.2% (P); p<0.001; −0.96% (E15) versus 0.2% (P); p<0.001 | FPG*: −34.56 (E5) versus (P); p<0.001; −43.92 (E15) versus (P); p<0.001 2hPPG*: −68.94 (E5) versus (P); p<0.001; −67.32 (E15) versus (P); p<0.001 |
| VERTIS MONO Extension20 (NCT01958671) | 384 | T2D uncontrolled with diet and exercise alone | 52 (26 P run in followed by 26 A control) | A1C change: −0.9% (E5); −1.0% (E15) no comparison to P as allowed to initiate metformin in this group |
FPG*: −28.8 (E5); −32.4 (E15) A1C <7%: 25.6% (E5) versus 28.5% (E15) |
| VERTIS SITA21 (NCT02226003) | 291 | T2D uncontrolled with diet and exercise alone | 26 | A1C change: −1.6% (E5/S100) versus −0.4% (P); p<0.001; −1.7% (E15/S100) versus −0.4% (P); p<0.001 | FPG*: −9.3 (P) versus −48.2 (E5/S100 ) versus −55.4 (E15/S100); p<0.001 A1C <7%: 8.3% (P) versus 35.7% (E5/S100) versus 31.3% (E15/S100); p<0.001 |
| VERTIS MET22 (NCT26378978) | 621 | T2D uncontrolled with metformin | 26 | A1C change: −0.7% (E5) versus 0% (P); p<0.001; −0.9% (E15) versus 0% (P); p<0.001 | FPG*: −34.56 (E5) versus (P); p<0.001; −43.92 (E15) versus (P); p<0.001 A1C <7%: 35% (E5) versus 16% (P); 40% (E15) versus 16% (P) |
| VERTIS FACTORIAL23 (NCT02099110) | 1233 | T2D uncontrolled with metformin | 26 | A1C change: −1.0% (E5) versus −1.1% (E15) versus −1.1% (S100) versus −1.5% (E5/S100) versus −1.4% (E15/S100) | FPG*: −35.7 (E5) versus −36.9 (E15) − 25.6 (S100) versus −44.0 (E5/S100) versus − 48.7 (E15/S100) A1C <7%: 26.4% (E5) versus 31.9% (E15) versus 32.8% (S100) versus 52.3% (E5/S100) versus 49.2% (E15/S100) |
| VERTIS SITA224 (NCT02036515) | 464 | T2D uncontrolled with metformin and sitagliptin | 26 | A1C change: −0.8% (E5) versus −0.2% (P); p<0.001; −0.9% (E15) versus −0.2% (P); p<0.001 | FPG*: −1.8 (P) versus −27.0 (E5) versus −32.4 (E15); p<0.001 A1C <7%: 17.0% (P) versus 32.1% (E5) versus 39.9% (E15); p<0.001 |
| VERTIS SU25 (NCT01999218) | 1326 | T2D uncontrolled with metformin | 52 | A1C change: −0.6% (E5) versus −0.7% (G); p<0.001; −0.6% (E15) versus −0.8% (G); p<0.001 | FPG*: −18.0 (E5) versus −16.2 (G); NS; −23.4 (E15) versus −16.2 (G); p<0.001 A1C <7%: 34.4% (E5) versus 43.5% (G); p=0.01; 38.0% (E15) versus 43.5% (G); NS |
| VERTIS RENAL13 (NCT01986855) | 468 | T2D uncontrolled with stage 3 CKD with insulin and/or sulfonylureas |
52 | A1C change: −0.3% (E5) versus −0.3% (P); p=0.81; −0.4% (E15) versus −0.3% (P); p=0.16 | Stage 3A CKD cohort A1C Change: −0.3% (E5) versus −0.3% (P); p=0.83; −0.4% (E15) versus −0.3% (P); p=0.50 |
| VERTIS CV26–28 (NCT01986881) | 8246 | T2D uncontrolled with ASCVD | 182 | MACE (CV death, MI, stroke): 11.9% (E) versus 11.9% (P); p<0.001 for non-inferiority | CV death: 1.8% (E) versus 1.9% (P); p=0.39 (ITT); non-fatal MI: 1.7% (E) versus 1.6% (P); p=0.66; non-fatal stroke: 0.8% (E) versus 0.8% p=0.006 (ITT) |
A, active; ASCVD, atherosclerotic cardiovascular disease; CKD, chronic kidney disease; CV, cardiovascular; E, ertugliflozin; FPG, fasting plasma glucose; G, glimepiride; HHF, hospitalization for heart failure; ITT, intention to treat; MACE, major cardiovascular event; mg, milligram; MI, myocardial infarction; NS, non-significant; P, placebo; S, sitagliptin; T2D, type 2 diabetes; 2hPPG, 2-hour postprandial glucose; wk, weeks;
*
mg/dL.