| |
PBO + MET (n = 137)
|
DAPA 2.5 mg + MET (n = 137)
|
DAPA 5 mg + MET (n = 137)
|
DAPA 10 mg + MET (n = 135)
|
|---|
|
Sodium (mmol/L)
| | | | |
|
n
|
72
|
77
|
87
|
93
|
|
Baseline
|
138.9 (2.3)
|
138.5 (2.9)
|
138.6 (2.3)
|
139.1 (2.2)
|
|
Change at week 102
|
-0.04 (2.7)
|
0.2 (2.8)
|
0.1 (2.6)
|
0.1 (2.6)
|
|
P vs PBO + MET
| |
0.1434
|
0.1905
|
0.3978
|
|
Potassium (mmol/L)
| | | | |
|
n
|
72
|
77
|
87
|
93
|
|
Baseline
|
4.35 (0.47)
|
4.34 (0.46)
|
4.37 (0.39)
|
4.37 (0.43)
|
|
Change at week 102
|
-0.08 (0.55)
|
-0.01 (0.45)
|
-0.05 (0.35)
|
-0.07 (0.47)
|
|
P vs PBO + MET
| |
0.3366
|
0.4563
|
0.9918
|
|
Serum creatinine (μmol/L)
| | | | |
|
n
|
72
|
77
|
88
|
93
|
|
Baseline
|
76.9 (17.9)
|
78.7 (18.1)
|
79.6 (19.3)
|
77.8 (17.8)
|
|
Change at week 102
|
-0.9 (10.3)
|
-1.8 (9.7)
|
-3.5 (12.7)
|
-2.7 (10.6)
|
|
P vs PBO + MET
| |
0.9954
|
0.4720
|
0.9032
|
|
Serum uric acid (μmol/L)
a
| | | | |
|
n
|
28
|
35
|
47
|
57
|
|
Baseline
|
314 (79)
|
322 (80)
|
323 (88)
|
323 (80)
|
|
Change at week 102
|
-1.78 (54.13)
|
-55.9 (50.32)
|
-46.4 (64.36)
|
-52.9 (64.36)
|
|
P vs PBO + MET
| |
0.0054
|
0.0013
|
0.0002
|
|
Blood urea nitrogen (mmol/L)
| | | | |
|
n
|
72
|
77
|
88
|
93
|
|
Baseline
|
5.33 (1.55)
|
5.51 (1.41)
|
5.65 (1.81)
|
5.34 (1.41)
|
|
Change at week 102
|
0.56 (1.24)
|
0.70 (1.54)
|
0.42 (1.87)
|
0.73 (1.44)
|
|
P vs PBO + MET
| |
0.2299
|
0.4169
|
0.0845
|
|
Haematocrit (%)
| | | | |
|
n
|
71
|
78
|
87
|
93
|
|
Baseline
|
42.61 (3.90)
|
42.38 (3.99)
|
42.15 (3.59)
|
42.88 (3.95)
|
|
Change at week 102
|
-1.43 (3.29)
|
0.84 (2.53)
|
1.35 (2.48)
|
1.54 (2.78)
|
|
P vs PBO + MET
| |
<0.0001
|
<0.0001
|
<0.0001
|
|
Haemoglobin (g/L)
| | | | |
|
n
|
71
|
78
|
87
|
94
|
|
Baseline
|
142.8 (13.45)
|
142.5 (14.25)
|
141.6 (12.19)
|
143.6 (13.10)
|
|
Change at week 102
|
-4.9 (10.14)
|
1.5 (7.73)
|
3.1 (8.40)
|
4.1 (8.84)
|
|
P vs PBO + MET
| |
<0.0001
|
<0.0001
|
<0.0001
|
|
Systolic blood pressure (mm Hg)
| | | | |
|
n
|
72
|
78
|
88
|
94
|
|
Baseline
|
128 (15)
|
127 (14)
|
127 (14)
|
126 (16)
|
|
Change at week 102
|
1.5 (13.7)
|
0.7 (16.1)
|
-1.1 (13.2)
|
-0.3 (15.0)
|
|
P vs PBO + MET
| |
0.1111
|
0.0136
|
0.0067
|
|
Diastolic blood pressure (mm Hg)
| | | | |
|
n
|
72
|
78
|
88
|
94
|
|
Baseline
|
81 (9)
|
80 (9)
|
81 (9)
|
79 (10)
|
|
Change at Week 102
|
-1.0 (7.9)
|
-0.1 (8.1)
|
-1.5 (8.1)
|
-1.2 (10.1)
|
|
P vs PBO + MET
| |
0.6605
|
0.2140
|
0.1075
|
- Data are means (SD) at baseline or mean changes (SD) from baseline at week 102 including data after rescue unless noted. n is the number of treated patients with non-missing baseline and Week 102 values for the specific test. aExcluding data after rescue. Abbreviations: SD standard deviation, SE standard error, PBO placebo, MET metformin, DAPA dapagliflozin.
