(b).
| Study 12 mo treatment period | Relative risk of experiencing ≥1 confirmed (blood glucose ≤ 70 mg/dL) or severe episode of hypoglycemia (95% CI) | Relative risk (95% CI) of documented symptomatic hypoglycemia (<54 mg/dL) | ||
|---|---|---|---|---|
| Nocturnal (00:00–05:59 h) BL to month 12 | At any time (24 h) BL to month 12 | BL to month 12 | BL to month 12 | |
| EDITION 1 | 0.84 (0.75 to 0.94) | 0.94 (0.89 to 0.99) | 0.91 (0.79 to 1.05) | 0.87 (0.66 to 1.13) |
| EDITION 2 | 0.84 (0.71 to 0.99) | 0.96 (0.89 to 1.02) | 0.92 (0.74 to 1.15) | 0.95 (0.67 to 1.36) |
| EDITION 3 | 0.86 (0.69 to 1.07) | 0.92 (0.82 to 1.03) | 0.65 (0.47 to 0.90) | 0.76 (0.48 to 1.22) |
| EDITION 4 | 0.97 (0.88 to 1.08) | 1.00 (0.96 to 1.05) | 0.98 (0.89 to 1.09) | 1.00 (0.84 to 1.18) |
| EDITION JP1 | 0.93 (0.83 to 1.05) | 1.00 (0.96 to 1.04) | 0.93 (0.85 to 1.01) | 0.79 (0.64 to 0.98) |
| EDITION JP2 | 0.73 (0.55 to 0.97) | 0.97 (0.85 to 1.10) | 1.03 (0.57 to 1.87) | 1.14 (0.51 to 2.55) |
BL: baseline; Glar-100: insulin glargine 100 U/mL; Glar-300: insulin glargine 300 U/mL; T1DM: type 1 diabetes mellitus; T2DM: type 2 diabetes mellitus; W8: week 8; W9: week 9.