Table 2.
Change in glycated haemoglobin (HbA1c) from baseline at Week 26 and Week 52
| Week 26 | Week 52a | |||||
|---|---|---|---|---|---|---|
| Placebo | Ertugliflozin 5 mg | Ertugliflozin 15 mg | Placebo | Ertugliflozin 5 mg | Ertugliflozin 15 mg | |
| Baseline | n = 152 | n = 155 | n = 152 | |||
| Mean (SD), mmol/mol | 64.3 (10.2) | 64.5 (9.4) | 64.0 (9.1) | |||
| Mean (SD), % | 8.0 (0.9) | 8.1 (0.9) | 8.0 (0.8) | |||
| Week 26 or 52 | n = 119 | n = 138 | n = 138 | n = 73 | n = 120 | n = 115 |
| Mean (SD), mmol/mol | 61.4 (10.7) | 55.7 (8.0) | 54.8 (8.9) | 56.7 (7.2) | 54.0 (8.0) | 53.0 (7.5) |
| Mean (SD), % | 7.7 (1.0) | 7.2 (0.7) | 7.2 (0.8) | 7.3 (0.7) | 7.1 (0.7) | 7.0 (0.7) |
| Change from baseline | ||||||
| n = 153 | n = 156 | n = 153 | n = 153 | n = 156 | n = 153 | |
| Mean (SD), mmol/mol | −1.7 (10.4) | −8.9 (8.8) | −9.4 (9.5) | −3.1 (9.3) | −9.2 (10.0) | −10.7 (8.7) |
| Mean (SD), % | −0.2 (1.0) | −0.8 (0.8) | −0.9 (0.9) | −0.3 (0.9) | −0.8 (0.9) | −1.0 (0.8) |
| LS mean (95% CI), mmol/mol | −1.0 (−2.5, 0.5) | −8.5 (−1.0, −7.1) | −9.4 (−10.8, −7.9) | 0.2 (−1.7, 2.1) | −8.1 (−9.8, −6.5) | −8.9 (−10.6, −7.2) |
| LS mean (95% CI), % | −0.1 (−0.2, 0.0) | −0.8 (−0.9, −0.6) | −0.9 (−1.0, −0.7) | 0.0 (−0.2, 0.2) | −0.7 (−0.9, −0.6) | −0.8 (−1.0, −0.7) |
| Difference in LS means vs placebo | ||||||
| n = 153 | n = 156 | n = 153 | n = 153 | n = 156 | n = 153 | |
| mmol/mol (95% CI) | – | −7.5 (−9.5, −5.5)* | −8.3 (−10.3, −6.3)* | – | −8.3 (−10.8, −5.9) | −9.1 (−11.5, −6.6) |
| % (95% CI) | – | −0.7 (−0.9, −0.5)* | −0.8 (−0.9, −0.6)* | – | −0.8 (−1.0, −0.5) | −0.8 (−1.1, −0.6) |
Abbreviations: CI, confidence interval; LS, least squares; SD, standard deviation; n, number of patients included in the analysis.
*
P <.001 vs placebo. Italic rows present the data in a different set of units.
a
Statistical testing was not performed at Week 52.