Table 4 Changes from baseline in secondary outcome measures other than glucose metabolism parameters
Parameter | Month | Adjusted mean change (95% CI)* | P†| ||
|---|---|---|---|---|---|
Ipragliflozin | Sitagliptin | Difference | Interaction | ||
Body weight (kg) | 1 | −0.7 (− 1.0; −0.5) | −0.2 (− 0.5; 0.0) | 0.009 |  |
3 | −1.2 (− 1.7; −0.8) | −0.1 (− 0.4; 0.2) | < 10− 4 |  | |
6 | −1.8 (− 2.3; −1.4) | −0.3 (− 0.7; −0.0) | < 10− 6 |  | |
Overall | −1.4 (− 1.7; −1.0) | −0.2 (− 0.5; 0.0) | < 10− 5 | < 10− 3 | |
Systolic BP (mmHg) | 1 | −3.9 (− 5.3; −2.6) | −1.7 (− 3.4; −0.0) | 0.04 |  |
3 | −4.1 (− 6.0; −2.3) | 0.8 (− 1.0; 2.7) | < 10− 3 |  | |
6 | −3.8 (− 5.5; −2.1) | 0.7 (− 1.3; 2.7) | 0.001 |  | |
Overall | −3.9 (− 5.2; −2.7) | −0.1 (− 1.5; 1.4) | < 10− 4 | 0.08 | |
Diastolic BP (mmHg) | 1 | −3.2 (− 4.7; −1.8) | −2.1 (− 3.4; −0.8) | 0.25 |  |
3 | −3.0 (− 4.7; −1.4) | −0.4 (− 1.9; 1.1) | 0.02 |  | |
6 | −3.4 (− 4.6; −2.2) | −0.7 (− 2.3; 0.8) | 0.008 |  | |
Overall | −3.2 (− 4.4; −2.0) | −1.1 (− 2.1; −0.1) | 0.009 | 0.28 | |
Cr-based eGFR (mL/min/1.73 m2) | 1 | −1.8 (− 4.6; 1.0) | −2.6 (− 4.4; −0.7) | 0.65 |  |
3 | −1.0 (− 3.2; 1.2) | −3.8 (− 5.6; −2.1) | 0.05 |  | |
6 | −2.4 (− 5.2; 0.5) | −5.1 (− 7.0; −3.3) | 0.11 |  | |
Overall | −1.7 (− 3.8; 0.4) | −3.9 (− 5.3; −2.5) | 0.10 | 0.45 | |
CysC-based eGFR (mL/min/1.73 m2) | 1 | −3.3 (− 5.5; −1.1) | −1.3 (− 2.8; 0.3) | 0.13 |  |
3 | −2.2 (− 4.4; −0.1) | −2.4 (− 4.0; −0.8) | 0.91 |  | |
6 | −3.4 (− 5.8; −1.0) | −2.9 (− 4.7; −1.1) | 0.76 |  | |
Overall | −3.0 (− 4.8; −1.2) | −2.2 (− 3.5; −0.9) | 0.49 | 0.28 | |
UACR (mg/g Cr)‡ | 1 | −0.12 (− 0.33; 0.08) | −0.15 (− 0.38; 0.08) | 0.87 |  |
3 | −0.16 (− 0.41; 0.09) | −0.17 (− 0.44; 0.10) | 0.95 |  | |
6 | −0.25 (− 0.48; −0.02) | −0.13 (− 0.38; 0.12) | 0.52 |  | |
Overall | −0.18 (− 0.34; −0.01) | −0.15 (− 0.34; 0.04) | 0.84 | 0.76 | |