Other efficacy outcomes at week 18 in VERTIS CV patients with CKD stage 3*
| Efficacy outcome | Placebo | Ertugliflozin 5 mg | Ertugliflozin 15 mg |
| HbA1c <7.0% | |||
| N† | 597 | 617 | 559 |
| Number (%) with HbA1c <7.0% | 77 (12.9) | 128 (20.7) | 95 (17.0) |
| Adjusted OR vs placebo (95% CI)‡ | — | 1.79 (1.28 to 2.50) | 1.46 (1.04 to 2.05) |
| P value vs placebo‡ | — | <0.001 | 0.03 |
| FPG | |||
| n/N† | 594/597 | 616/617 | 557/559 |
| Baseline mean (SD)—mg/dL | 172.3 (52.95) | 175.2 (55.31) | 173.1 (58.52) |
| LS-mean change from baseline (95% CI)§ | −22.78 (−26.55 to –19.02) | −30.63 (−34.23 to –27.03) | −31.99 (−35.69 to –28.29) |
| Difference in LS-mean vs placebo (95% CI)§ | — | −7.85 (−12.23 to –3.47) | −9.21 (−13.67 to –4.74) |
| P value vs placebo¶ | — | <0.001 | <0.001 |
| Body weight | |||
| n/N† | 597/597 | 617/617 | 560/560 |
| Baseline mean (SD)—kg | 92.5 (19.04) | 91.6 (17.85) | 91.6 (19.35) |
| LS-mean change from baseline (95% CI)§ | −0.41 (−0.65 to –0.17) | −1.77 (−2.01 to –1.54) | −1.93 (−2.18 to –1.69) |
| Difference in LS-mean vs placebo (95% CI)§ | — | −1.37 (−1.70 to –1.04) | −1.53 (−1.86 to –1.19) |
| P value vs placebo¶ | — | <0.001 | <0.001 |
| SBP | |||
| n/N† | 597/597 | 615/617 | 560/560 |
| Baseline mean (SD)—mm Hg | 132.7 (15.18) | 134.7 (14.85) | 133.6 (14.47) |
| LS-mean change from baseline (95% CI)§ | 0.90 (−0.30 to 2.09) | −1.99 (−3.15 to –0.83) | −2.29 (−3.50 to –1.08) |
| Difference in LS-mean vs placebo (95% CI)§ | — | −2.89 (−4.48 to –1.30) | −3.19 (−4.81 to –1.56) |
| P value vs placebo¶ | — | <0.001 | <0.001 |
*CKD stage was based on eGFR calculated using the MDRD equation.
†n is the number of patients with non-missing assessments at baseline; N is the number of patients in the cLDA FAS (ie, randomized patients who took at least one dose of study medication and had at least one assessment at or after baseline).
‡Adjusted OR based on a logistic regression model fitted with fixed effects for treatment, and covariates for baseline HbA1c and baseline eGFR (continuous). Missing data were imputed using the cLDA model fitted with fixed effects as in the primary analysis.
§Calculated using a cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time (categorical) by treatment.
¶Nominal p values.
CKD, chronic kidney disease; CKD stage 3, eGFR 30–<60 mL/min/1.73 m2; cLDA, constrained longitudinal data analysis; eGFR, estimated glomerular filtration rate; FAS, full analysis set; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; LS, least squares; MDRD, Modification of Diet in Renal Disease; SBP, systolic blood pressure.