Table 2.
Efficacy measurements in the overall study population and in the corresponding strata of age <65 years and age ≥65 years (full analysis set)
| Full analysis set |
Age <65 years |
Age ≥65 years§* |
||||
|---|---|---|---|---|---|---|
| Placebo group (n = 459) | Dapagliflozin 10 mg group (n = 455) | Placebo group (n = 263) | Dapagliflozin 10 mg group (n = 263) | Placebo group (n = 196) | Dapagliflozin 10 mg group (n = 192) | |
| HbA1c at 24 weeks* | ||||||
| n | 451 | 448 | 259 | 260 | 192 | 188 |
| Baseline, mean (SD) | ||||||
| % | 8.08 (0.80) | 8.18 (0.84) | 8.06 (0.82) | 8.22 (0.86) | 8.10 (0.79) | 8.13 (0.81) |
| mmol/mol | 65 (8.7) | 66 (9.2) | 65 (9.0) | 66 (9.4) | 65 (8.6) | 65 (8.9) |
| Change from baseline, adjusted mean (95% CI) | ||||||
| % | 0.08 (0.01–0.16) | −0.38# (−0.46 to −0.30) | 0.02 (−0.08 to 0.12) | −0.40# (−0.50 to −0.30) | 0.16 (0.04–0.28) | −0.37# (−0.49 to −0.25) |
| mmol/mol | 0.9 (0.1–1.7) | –4.2# (−5.0 to 3.3) | 0.2 (−0.9 to 1.3) | −4.4# (−5.5 to −3.3) | 1.7 (0.4–3.1) | −4.0# (−5.4 to −2.7) |
| Responders of three-item end point at 24 weeks* | ||||||
| x/n | 4/451 | 52/444 | 1/259 | 29/258 | 3/192 | 23/186 |
| % (95% CI) | 0.9 (0.0–1.8) | 11.7# (8.7–14.7) | 0.4 (−0.4 to 1.1) | 11.2# (7.4–15.1) | 1.6 (−0.2 to 3.3) | 12.4# (7.6–17.1) |
| Seated SBP at 8 weeks, mmHg†** | ||||||
| n | 459 | 451 | 263 | 261 | 196 | 190 |
| Baseline, mean (SD) | 132.99 (13.81) | 133.39 (13.48) | 131.51 (14.09) | 132.72 (13.44) | 134.96 (13.20) | 134.31 (13.51) |
| Change from baseline, adjusted mean (95% CI) | −0.99 (−2.29 to 0.32) | −2.96§ (−4.29 to −1.64) | 0.01 (−1.67 to 1.70) | −3.10‖ (−4.79 to −1.42) | −2.30 (−4.29 to −0.31) | −2.77 (−4.82 to −0.73) |
| BW at 24 weeks, kg† | ||||||
| n | 459 | 455 | 263 | 263 | 196 | 192 |
| Baseline, mean (SD) | 93.59 (19.47) | 92.63 (20.50) | 93.74 (20.18) | 94.27 (20.70) | 93.38 (18.51) | 90.39 (20.07) |
| Change from baseline, adjusted mean (95% CI), % | −0.30 (−0.62 to 0.03) | −2.56# (−2.88 to −2.24) | −0.11 (−0.52 to 0.31) | −2.40# (−2.80 to −2.00) | −0.49 (−0.98 to 0.01) | −2.73†† (−3.23 to −2.23) |
| Seated SBP at 24 weeks, mmHg† | ||||||
| n | 459 | 451 | 263 | 261 | 196 | 190 |
| Baseline, mean (SD) | 132.99 (13.81) | 133.39 (13.48) | 131.51 (14.09) | 132.72 (13.44) | 134.96 (13.20) | 134.31 (13.51) |
| Change from baseline, adjusted mean (95% CI) | −1.03 (−2.39 to 0.32) | −2.99§ (−4.36 to −1.61) | 0.05 (−1.57 to 1.66) | −2.94‖ (−4.56 to −1.32) | −2.38 (−4.66 to −0.10) | −3.03†† (−5.37 to −0.69) |
| Patients with BW decrease of ≥5% in patients with baseline BMI of ≥27 kg/m2† | ||||||
| x/n | 16/397 | 64/388 | 8/221 | 36/224 | 8/176 | 28/164 |
| % (95% CI) | 4.0 (2.1–5.9) | 16.5# (12.8–20.2) | 3.6 (1.2–6.1) | 16.1# (11.3–20.9) | 4.5 (1.4–7.6) | 17.1†† (11.2–22.8) |
| FPG, mmol/L‡ | ||||||
| n | 441 | 437 | 255 | 256 | 186 | 181 |
| Baseline, mean (SD) | 8.77 (2.34) | 8.89 (2.59) | 8.95 (2.39) | 8.92 (2.49) | 8.52 (2.24) | 8.84 (2.74) |
| Change from baseline, adjusted mean (95% CI) | 0.35 (0.13–0.57) | −0.57§ (−0.78 to −0.34) | 0.23 (−0.04 to 0.49) | −0.56# (−0.83 to −0.30) | 0.52 (0.17–0.87) | −0.57# (−0.93 to −0.22) |
This was a last observation carried forward analysis. x, number of responders; n, number of patients in the full analysis set with nonmissing baseline and week t (last observation carried forward) values.
*Co-primary end point. †Key secondary end point. ‡Other end point. §P < 0.05. ‖P < 0.01. #P < 0.0001. **The protocol mandated that antihypertensive medication was unchanged during the first 8 weeks of the study. Analyses excluded data after glycemic rescue and included data after antihypertensive rescue for HbA1c, excluded data after glycemic and hypertension rescue for the three-item end point, included data after glycemic and antihypertensive rescue for BW end points, and included data after glycemic rescue and excluded data after antihypertensive rescue for seated SBP end points. ††Statistical testing was not performed in the stratum of age ≥65 years for the key secondary end points of change in BW, change in seated SBP at 24 weeks, and patients with a BW decrease of ≥5% among patients with a baseline BMI of ≥27 kg/m2, because the first key secondary end point did not meet statistical significance.