| |
Study 1 |
Study 2 |
Study 3 |
Study 4 |
Study 5 |
Study 6 |
| |
(N=64) |
(N=74) |
(N=64) |
(N=64) |
(N=64) |
(N=83) |
| Completion/withdrawal |
|
|
|
|
|
|
| Enrolled, n (%) |
64 (100) |
74 (100) |
64 (100) |
64 (100) |
64 (100) |
83 (100) |
| Completed, n (%) |
59 (92.2) |
62 (83.8) |
58 (90.6) |
60 (93.8) |
61 (95.3) |
62 (74.7) |
| Withdrawn, n (%) |
5 (7.8) |
12 (16.2) |
6 ( 9.4) |
4 ( 6.3) |
3 ( 4.7) |
21 (25.3) |
| Adverse event |
1 (1.6) |
4 (5.4) |
6 ( 9.4) |
1 ( 1.6) |
2 ( 3.1) |
9 (10.8) |
| Withdrawal of consent |
- |
- |
- |
1 ( 1.6) |
- |
3 (3.6) |
| Other |
4 (6.3) |
8 (10.8) |
- |
3 (4.7) |
1 ( 1.6) |
9 (10.8) |
| Most common TEAEs |
|
|
|
|
|
|
| Any adverse event, n (%) |
35 (54.7) |
48 (64.9) |
35 (54.7) |
33 (51.6) |
44 (68.8) |
60 (72.3) |
| Gastrointestinal disorders, n (%) |
26 (40.6) |
41 (55.4) |
27 (42.2) |
19 (29.7) |
35 (54.7) |
53 (63.9) |
| Diarrhea |
16 (25.0) |
28 (37.8) |
22 (34.4) |
13 (20.3) |
28 (43.8) |
29 (34.9) |
| Nausea |
11 (17.2) |
21 (28.4) |
14 (21.9) |
7 (10.9) |
13 (20.3) |
27 (32.5) |
| Nervous system disorders, n (%) |
16 (25.0) |
16 (21.6) |
9 (14.1) |
15 (23.4) |
19 (29.7) |
23 (27.7) |
| Headache |
13 (20.3) |
14 (18.9) |
7 (10.9) |
8 (12.5) |
15 (23.4) |
14 (16.9) |
Note: Total treatment dose of canagliflozin and metformin administered as 2 IR FDC tablets or coadministered as single-component canagliflozin and metformin: 100 mg CANA, 1000 mg MET (Study 1); 100 mg CANA, 1700 mg MET (Study 2); 100 mg CANA, 2000 mg MET (Study 3); 300 mg CANA, 1000 mg MET (Study 4); 300 mg CANA, 1700 mg MET (Study 5); 300 mg CANA, 2000 mg MET (Study 6); IR = immediate release; FDC = fixed-dose combination; CANA = canagliflozin; MET = metformin; TEAE = treatment-emergent adverse events; N = total sample size; n = size of subsample. |
