Table 5.
Percent change from baseline at week 26 in serum lipids (mg/dl), placebo pool
| N | Baseline | N | Week 26 | Percent change from baseline at week 26 | Difference vs. placebo | |
|---|---|---|---|---|---|---|
| Total cholesterola | ||||||
| Placebo | 503 | 179.74 (42.18) | 455 | 177.25 (39.60) | 1.06 (–0.57, 2.69) | |
| Ertugliflozin 5 mg | 506 | 178.46 (40.96) | 479 | 180.70 (40.12) | 2.59 (1.00, 4.19) | 1.53 (–0.68, 3.74) |
| Ertugliflozin 15 mg | 495 | 176.65 (41.65) | 463 | 183.00 (41.15) | 5.06 (3.44, 6.68) | 4.00 (1.77, 6.23) |
| Low-density lipoprotein cholesterola | ||||||
| Placebo | 501 | 97.69 (35.41) | 452 | 94.87 (33.12) | 2.75 (–0.20, 5.70) | |
| Ertugliflozin 5 mg | 505 | 96.85 (33.91) | 475 | 98.89 (35.06) | 5.33 (2.45, 8.22) | 2.58 (–1.43, 6.59) |
| Ertugliflozin 15 mg | 490 | 96.61 (34.38) | 455 | 100.22 (33.71) | 8.14 (5.18, 11.09) | 5.39 (1.33, 9.45) |
| High-density lipoprotein cholesterola | ||||||
| Placebo | 503 | 47.12 (13.45) | 455 | 47.51 (13.02) | 1.68 (0.18, 3.18) | |
| Ertugliflozin 5 mg | 506 | 47.56 (13.44) | 479 | 49.71 (13.89) | 6.23 (4.77, 7.70) | 4.56 (2.49, 6.63) |
| Ertugliflozin 15 mg | 495 | 47.31 (11.72) | 463 | 50.39 (12.38) | 7.52 (6.02, 9.02) | 5.84 (3.75, 7.93) |
| Triglyceridesb | ||||||
| Placebo | 503 | 143.0 (106.0) | 444 | 147.5 (92.6) | 4.5 (45.7)/3.7 | |
| Ertugliflozin 5 mg | 508 | 144.5 (101.4) | 470 | 140.5 (84.7) | –3.9 (41.1)/–3.3 | –7.0 (–11.5, –2.4) |
| Ertugliflozin 15 mg | 496 | 141.0 (82.8) | 450 | 134.5 (80.0) | –1.7 (41.6)/–1.3 | –4.9 (–9.5, –0.3) |
CI confidence interval, eGFR estimated glomerular filtration rate, LS least squares, SD standard deviation
aBaseline and week 26 data are mean (SD). Percent change from baseline data are LS mean (95% CI) with difference in LS means (95% CI). Based on a constrained longitudinal data analysis model with fixed effects for trial, treatment, time, baseline eGFR (continuous), and the interaction of time by treatment, with time treated as a categorical variable. At baseline and week 26, N is the number of patients with measurements at the respective time point
bBaseline and week 26 data are median (SD). Percent change from baseline data are median (SD)/M-estimate with difference in M-estimates (95% CI). From fitting a robust regression model with terms for trial, treatment, and covariates baseline triglycerides and baseline eGFR (continuous), after imputing for missing values using multiple imputation. At baseline N is the number of patients with a baseline measurement, and at week 26 N is the number of patients with measurements at baseline and at week 26