Table S1.
Study | Arms | Mean change from baseline HbA1c %
|
HbA1c difference vs PBO
|
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---|---|---|---|---|---|---|---|---|---|
To end of main study
|
To end of extension
|
To end of main study
|
To end of extension
|
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LS mean | (95% CI) | LS mean | (95% CI) | LS mean | (95% CI) | LS mean | (95% CI) | ||
VERTIS MONO1,2 | PBO (n=153) | 0.2 | (0.02–0.37) | – | – | – | – | – | – |
ERTU 5 mg (n=155) | −0.79 | (−0.95, −0.63) | −0.74 | (−0.89, −0.58) | −0.99* | (−1.22, −0.76) | – | – | |
ERTU 15 mg (n=155) | −0.96 | (−1.12, −0.80) | −0.89 | (−1.05, −0.74) | −1.16* | (−1.39, −0.93) | – | – | |
VERTIS MET3 | PBO (n=209) | – | – | – | – | – | – | – | – |
ERTU 5 mg (n=207) | – | – | – | – | −0.70* | (−0.87, −0.53) | – | – | |
ERTU 15 mg (n=205) | – | – | – | – | −0.88* | (−1.05, −0.71) | – | – | |
VERTIS FACTORIAL4,5 | ERTU 5 mg (n=250) | −1.0 | (−1.1, −0.9) | −0.96 | (−1.10, −0.82) | – | – | – | – |
ERTU 15 mg (n=248) | −1.1 | (−1.2, −1.0) | −0.93 | (−1.07, −0.79) | – | – | – | – | |
SITA 100 mg (n=247) | −1.1 | (−1.2, −0.9) | −0.82 | (−0.97, −0.68) | – | – | – | – | |
ERTU 5 mg + SITA 100 mg (n=243) | −1.5a | (−1.6, −1.4) | −1.36 | (−1.50, −1.22) | – | – | – | – | |
ERTU 15 mg + SITA 100 mg (n=244) | −1.5a | (−1.6, −1.4) | −1.39 | (−1.53, −1.25) | – | – | – | – | |
VERTIS SITA6 | PBO (n=96) | −0.44 | (−0.69, −0.19) | – | – | – | – | – | – |
ERTU 5 mg + SITA 100 mg (n=98) | −1.60 | (−1.82, −1.39) | – | – | −1.16* | (−1.49, −0.84) | – | – | |
ERTU 15 mg + SITA 100 mg (n=96) | −1.68 | (−1.90, −1.46) | – | – | −1.24* | (−1.57, −0.91) | – | – | |
VERTIS SITA 27,8 | PBO (n=153) | −0.1 | (−0.23, 0.04) | 0.02 | (−0.15, 0.19) | – | – | – | – |
ERTU 5 mg (n=156) | −0.78 | (−0.91, −0.65) | −0.75 | (−0.90, −0.59) | −0.68* | (−0.87, −0.50) | −0.76 | (−0.98, −0.54) | |
ERTU 15 mg (n=155) | −0.86 | (−0.99, −0.72) | −0.81 | (−0.97, −0.66) | −0.76* | (−0.95, −0.58) | −0.83 | (−1.05, −0.61) | |
| |||||||||
Mean change from baseline HbA1c % | HbA1c difference vs glimepiride | ||||||||
| |||||||||
VERTIS SU9 | ERTU 5 mg (n=448) | −0.6 | NA | 0.2 | (0.1, 0.3) | ||||
ERTU 15 mg (n=440) | −0.6 | NA | 0.1 | (−0.0, 0.2)* | |||||
Titrated glimepiride (n=437) | −0.7 | NA |
Notes:
p<0.001.
p<0.004 versus individual treatment.
Abbreviations: ERTU, ertugliflozin; SITA, sitagliptin; PBO, placebo; HbA1c, glycated hemoglobin.