Table 5.
Summary of key clinical trial results: teneligliptin safety
| Study type | Phase II (monotherapy) | Phase III (monotherapy) | Phase III (combination therapy) | Phase IV (combination therapy) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 3000-A4 [41] [n (%)] | 3000-A5 [24] [n (%)] | 3000-A6 [42] [n (%)] | 3000-A7 [43] [n (%)] | 3000-A15 [44] [n (%)] | ||||||
| Placebo | TNL | Placebo | TNL | SU | SU + TNL | PIO | PIO + TNL | Insulin | Insulin + TNL | |
| (a) Double-blind trials | ||||||||||
| N | 80 | 79 | 104 | 99 | 98 | 96 | 101 | 103 | 71 | 77 |
| AE | 44 (55.0) | 40 (50.6) | 66 (63.5) | 62 (62.6) | 61 (62.2) | 62 (64.6) | 47 (46.5) | 63 (61.2) | 38 (53.5) | 34 (44.2) |
| ADR | 6 (7.5) | 2 (2.5) | 5 (4.8) | 1 (1.0) | 6 (6.1) | 8 (8.3) | 2 (2.0) | 12 (11.7) | 5 (7.0) | 5 (6.5) |
| SAE | 1 (1.3) | 0 (0.0) | 4 (3.8) | 0 (0.0) | 2 (2.0) | 0 (0.0) | 1 (1.0) | 4 (3.9) | 2 (2.8) | 1 (1.3) |
| Discontinued because of AE | 2 (2.5) | 1 (1.3) | 2 (1.9) | 2 (2.0) | 2 (2.0) | 1 (1.0) | 2 (2.0) | 1 (1.0) | 4 (5.6) | 0 (0.0) |
| Hypoglycemia | 3 (3.8) | 1 (1.3) | 1 (1.0) | 1 (1.0) | 3 (3.1) | 2 (2.1) | 0 (0.0) | 2 (1.9) | 5 (7.0) | 9 (11.7) |
| Study type | Phase III (monotherapy) | Phase III (combination therapy) | |||||
|---|---|---|---|---|---|---|---|
| 3000-A8/A14 [45] [n (%)] | 3000-A8/A14 [45] [n (%)] | 3000-A6 [42] [n (%)] | 3000-A7, A8a [43, 45] [n (%)] | 3000-A15 [44] [n (%)] | |||
| TNL | GLI + TNL | BG + TNL | αGI + TNL | PIO + TNL | SU + TNL | Insulin + TNL | |
| (b) Long-term trials | |||||||
| N | 363 | 80 | 95 | 75 | 201 | 280 | 140 |
| AE | 320 (88.2) | 72 (90.0) | 82 (86.3) | 60 (80.0) | 178 (88.6) | 266 (95.0) | 102 (72.9) |
| ADR | 31 (8.5) | 10 (12.5) | 7 (7.4) | 5 (6.7) | 23 (11.4) | 53 (18.9) | 23 (16.4) |
| SAE | 20 (5.5) | 3 (3.8) | 6 (6.3) | 6 (8.0) | 14 (7.0) | 16 (5.7) | 10 (7.1) |
| Discontinued because of AE | 11 (3.0) | 5 (6.3) | 5 (5.3) | 5 (6.7) | 9 (4.5) | 19 (6.8) | 1 (0.7) |
| Hypoglycemia | 9 (2.5) | 4 (5.0) | 1 (1.1) | 1 (1.3) | 3 (1.5) | 30 (10.7) | 28 (20.0) |
Medical Dictionary for Regulatory Activities/Japanese (MedDRA/J), version 11.1, 13.0, 13.1, and 15.0
ADR adverse drug reaction, AE adverse event, αGI α-glucosidase inhibitor, BG biguanide, GLI glinide, n number of patients, PIO pioglitazone, SU sulfonylurea, SAE serious adverse event, TNL teneligliptin
aPooled analysis using data from the 3000-A7 and A8 studies