Table S2.
Mean change in body weight
| Study | Arms | Mean change from baseline (kg)
|
Weight difference vs PBO (kg)
|
||||||
|---|---|---|---|---|---|---|---|---|---|
| To end of main study
|
To end of extension
|
To end of main study
|
To end of extension
|
||||||
| LS mean | (95% CI) | LS mean | (95% CI) | LS mean | (95% CI) | LS mean | (95% CI) | ||
| VERTIS MONO1,2 | PBO (n=153) | – | – | – | – | – | – | – | – |
| ERTU 5 mg (n=155) | – | – | −3.23 | (−3.91, −2.55) | −1.76* | (−2.57, −0.95) | – | – | |
| ERTU 15 mg (n=155) | – | – | −3.38 | (−4.06, −2.71) | −2.16* | (−2.98, −1.34) | – | – | |
| VERTIS MET3 | PBO (n=209) | – | – | – | – | – | – | – | – |
| ERTU 5 mg (n=207) | – | – | – | – | −1.67* | (−2.24, −1.11) | – | – | |
| ERTU 15 mg (n=205) | – | – | – | – | −1.60* | (−2.16, −1.03) | – | – | |
| VERTIS FACTORIAL4,5 | ERTU 5 mg (n=250) | −2.7 | (−3.1, −2.3) | −2.4 | (−2.9, −1.8) | – | – | – | – |
| ERTU 15 mg (n=248) | −3.7 | (−4.2, −3.3) | −3.2 | (−3.8, −2.7) | – | – | – | – | |
| SITA 100 mg (n=247) | −0.7 | (−1.1, −0.2) | −0.1 | (−0.7, 0.5) | – | – | – | – | |
| ERTU 5 mg + SITA 100 mg (n=243) | −2.5ª | (−3.0, −2.1) | −2.4 | (−3.0, −1.8) | – | – | – | – | |
| ERTU 15 mg + SITA 100 mg (n=244) | −2.9ª | (−3.4, −2.5) | −2.8 | (−3.4, −2.2) | – | – | – | – | |
| VERTIS SITA6 | PBO (n=96) | −0.9 | (−1.7, −0.2) | – | – | – | – | – | – |
| ERTU 5 mg + SITA 100 mg (n=98) | −2.9 | (−3.6, −2.3) | – | – | −2.0* | (−3.0, −1.0) | – | – | |
| ERTU 15 mg + SITA 100 mg (n=96) | −3.0 | (−3.7, −2.4) | – | – | −2.1* | (−3.1, −1.1) | – | – | |
| VERTIS SITA 27,8 | PBO (n=153) | −1.3 | (−1.8, −0.9) | −1.0 | (−1.7, −0.3) | – | – | – | |
| ERTU 5 mg (n=156) | −3.3 | (−3.8, −2.9) | −3.5 | (−4.1, −2.9) | −2.0* | (−2.6, −1.4) | −2.5 | (−3.4, −1.6) | |
| ERTU 15 mg (n=155) | −3.0 | (−3.5, −2.6) | −2.8 | (−3.4, −2.2) | −1.7* | (−2.3, −1.1) | −1.9 | (−2.8, −1.0) | |
|
| |||||||||
| Mean change from baseline (kg) | Weight difference vs glimepiride (kg) | ||||||||
|
| |||||||||
| VERTIS SU9 | ERTU 5 mg (n=448) | −3.0 | −3.9 | (−4.4, −3.4)* | |||||
| ERTU 15 mg (n=440) | −3.4 | −4.3 | (−4.8, −3.8)b | ||||||
| Titrated glimepiride (n=437) | 0.9 | ||||||||
Notes:
*
p<0.001;
a
p<0.005 vs SITA;
b
nominal p<0.001 (non-inferiority for HbA1c not demonstrated for ERTU 5 vs glimepiride and the multiplicity strategy did not permit testing of any further secondary hypotheses).
Abbreviations: ERTU, ertugliflozin; SITA, sitagliptin; PBO, placebo.