Table 3.
Hypoglycemic events
| Level | Placebo | Empagliflozin | Estimated rate ratio† (95% CI) | Participants with events during both interventions, n‡ | ||||
|---|---|---|---|---|---|---|---|---|
| Participants with events, n/n (%) | Total events | Events per participant, n* | Participants with events, n/n (%) | Total events | Events per participant, n* | |||
| CGM | ||||||||
| 1 + 2 | 8/18 (44) | 42 | 0 [0, 2] | 12/18 (67) | 72 | 4 [0, 6] | 2.5 (0.7 to 8.6), P = 0.15 | 7, P = 0.22 (0.13) |
| 1§ | 8/18 (44) | 31 | 0 [0, 2] | 12/18 (67) | 57 | 3 [0, 5] | 1.9 (0.6 to 5.9), P = 0.27 | 7, P = 0.22 (0.13) |
| 2‖ | 4/18 (22) | 11 | 0 [0, 0] | 8/18 (44) | 15 | 0 [0, 2] | 1.9 (0.6 to 6.1), P = 0.30 | 2, P = 0.29 (0.18) |
| Participant-reported events | ||||||||
| 1 + 2 | 3/19 (16) | 7 | 0 [0, 0] | 5/18 (28) | 9 | 0 [0, 1] | 1.3 (0.4 to 4.2), P = 0.64 | 3, P = 0.48 (0.25) |
| 1 | 3/19 (16) | 5 | 0 [0, 0] | 5/18 (28) | 7 | 0 [0, 1] | 1.4 (0.4 to 4.7), P = 0.59 | 3, P = 0.48 (0.25) |
| 2 | 2/19 (11) | 2 | 0 [0, 0] | 2/18 (11) | 2 | 0 [0, 0] | — | 1, P > 0.99 (>0.99) |
Hypoglycemic events in the safety population (n = 19). No level 3 hypoglycemic events (i.e., severe events requiring assistance) occurred.
*Events per participant are given as the observed count (median [quartile 1, quartile 3]).
†Rate ratio could not be estimated for participant-reported hypoglycemic events level 2 owing to convergence issues.
‡Significance test for the number of participants with event(s) derived from the McNemar test (in parentheses: worst-case analysis assuming a hypoglycemic event during empagliflozin for participant who discontinued the study).
§Level 1 hypoglycemia: plasma glucose between 3.0 and 3.8 mmol/L.
‖Level 2 hypoglycemia: plasma glucose <3.0 mmol/L.