Table 1.
Summary of adverse events
| Participants in population with event, n (%) | Placebo/glimepiride (N = 209) | Ertugliflozin 5 mg (N = 207) | Ertugliflozin 15 mg (N = 205) |
|---|---|---|---|
| ≥1 AE | |||
| Overall | 159 (76.1) | 146 (70.5) | 155 (75.6) |
| Drug‐relateda | 49 (23.4) | 37 (17.9) | 48 (23.4) |
| ≥1 serious AE | |||
| Overall | 20 (9.6) | 19 (9.2) | 20 (9.8) |
| Drug‐relateda | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Discontinued study medication | |||
| Because of AE | 5 (2.4) | 7 (3.4) | 8 (3.9) |
| Because of drug‐relateda AE | 3 (1.4) | 3 (1.4) | 4 (2.0) |
| Because of serious AE | 1 (0.5) | 2 (1.0) | 3 (1.5) |
| Because of serious drug‐relateda AE | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Deathsb | 3 (1.4) | 1 (0.5) | 2 (1.0) |
| Prespecified AEs of special interest | |||
| Symptomatic hypoglycaemiac | 28 (13.4) | 12 (5.8) | 12 (5.9) |
| UTI | 15 (7.2) | 9 (4.3) | 22 (10.7) |
| GMI, femaled | 1 (0.9) | 8 (7.3) | 11 (9.8) |
| GMI, male | 2 (2.0) | 5 (5.2) | 5 (5.4) |
| Hypovolemia | 3 (1.4) | 5 (2.4) | 5 (2.4) |
Abbreviations: AE, adverse event; GMI, genital mycotic infection; UTI, urinary tract infection.
Assessed as related to the study drug by the investigator.
Two participants died more than 14 days after the last dose of study medication: 1 in the ertugliflozin 5 mg group (caused by acute heart failure) and another in the placebo/glimepiride group (caused by myocardial infarction). For the 4 deaths that occurred between the first dose of study medication and 14 days after the last dose of study medication, the causes were: plasma cell myeloma and unknown (ertugliflozin 15 mg), and hepatic cancer and cardiac death (placebo/glimepiride). None of the deaths was considered related to study medication by the investigators. For all other AEs, this table contains events that occurred between the first dose of treatment and 14 days after the last dose of treatment.
P = 0.009 for both ertugliflozin groups versus placebo/glimepiride.
P = 0.017 for ertugliflozin 5 mg versus placebo/glimepiride; P = 0.003 for ertugliflozin 15 mg versus placebo/glimepiride.