Table 2. Safety of SGLT2 inhibitors.
| n | ≥1 AE | ≥1 SAE | Disc for AEs | Hypoglycaemia | |||
|---|---|---|---|---|---|---|---|
| Overall | Major/Severe† | ||||||
| Add-on to MET45 | Study duration: 24 weeks | ||||||
| DAPA 10mg | 135 | 98 (73) | 4 (3) | 4 (3) | 5 (4) | 0 | |
| PBO | 137 | 88 (64) | 5 (4) | 5 (4) | 4 (3) | 0 | |
| Study duration: 26 week | |||||||
| CANA 300mg | NA | NA | NA | NA | NA | ||
| CANA 100mg | |||||||
| PBO | |||||||
| Add-on to SU*30,34,37 | Study duration: 24 weeks | ||||||
| DAPA 10mg | 151 | 76 (50.3) | 9 (6.0) | 4 (2.6) | 12 (7.9) | 0 | |
| PBO | 146 | 69 (47.3) | 7 (4.8) | 3 (2.1) | 7 (4.8) | ||
| Study duration: 26 weeks | |||||||
| CANA 300mg | 156 | 97 (62.2) | 6 (3.8) | 9 (5.8) | 30.1% | ≤1 | |
| CANA 100mg | 157 | 90 (57.3) | 5 (3.2) | 9 (5.7) | 26.8% | ≤1 | |
| PBO | 156 | 100 (64.1) | 9 (5.8) | 5 (3.2) | 15.4% | ≤1 | |
| Add-on to INS23,35 | Study duration: 48 weeks | ||||||
| DAPA 10mg | 196 | 145 (74.0) | 23 (11.7) | 10 (5.1) | 105 (53.6) | 3 (1.5) | |
| PBO | 197 | 144 (73.1) | 26 (13.2) | 9 (4.6) | 102 (51.8) | 2 (1.0) | |
| Study duration: 18 weeks | |||||||
| CANA 300mg | 587 | 382 (65.1) | 31 (5.3) | 32 (5.5) | 48.6% | 0.027 | |
| CANA 100mg | 566 | 362 (64.0) | 31 (5.5) | 11 (1.9) | 49.3% | 0.018 | |
| PBO | 565 | 334 (59.1) | 36 (6.4) | 12 (2.1) | 36.8% | 0.025 | |
| SGLT2 inhibitor vs SU29,33,46 | Study duration: 52 weeks | ||||||
| DAPA 10mg | 406 | 318 (78.3) | 35 (8.6) | 37 (9.1) | 14 (3.4) | 0 | |
| GLIP (up to 20mg) | 408 | 318 (77.9) | 46 (11.3) | 24 (5.9) | 162 (39.7) | 3 (0.7) | |
| Study duration: 52 weeks | |||||||
| CANA 300mg | 485 | 332 (68.5) | 26 (5.4) | 32 (6.6) | 4.9% | ||
| CANA 100mg | 483 | 311 (64.4) | 24 (5.0) | 25 (5.2) | 5.6% | NA | |
| GLIM (up to 8mg) | 482 | 330 (68.5) | 39 (8.1) | 28 (5.8) | 34.2% | ||
AE=adverse event; CANA=canagliflozin; DAPA=dapagliflozin; Disc=discontinuations; GLIM=glimepiride; GLIP=glipizide; INS=insulin; MET=metformin; NA=not applicable; PBO=placebo; SAE=serious AE; SGLT2=sodium glucose co-transporter 2; SU=sulphonylurea.
Results from the DAPA and CANA studies should not be directly compared due to their different study designs.
Data are n (%).
Major episodes in DAPA studies were defined as symptomatic episodes requiring third-party assistance due to severe impairment in consciousness or behaviour, with a capillary or plasma glucose value <54 mg/dL, and prompt recovery after glucagon administration. Severe hypoglycaemia episodes in CANA studies were defined as episodes requiring the assistance of another individual or resulting in seizure or loss of consciousness.
Patients in the DAPA study were receiving SU monotherapy (GLIM 4mg) at baseline. Patients in the CANA study were receiving stable doses of SU+MET at baseline.
Results from the DAPA and CANA studies should not be directly compared due to their different study designs.