(a).
| Study 6 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) | At any time (24 h) | At any time | Nocturnal | |||||
| BL to W8 | W9 to month 6 | BL to month 6 | BL to W8 | W9 to month 6 | BL to month 6 | BL to month 6 | BL to month 6 | |
| EDITION 1 | 0.79 (0.64 to 0.98) | 0.79 (0.67 to 0.93) | 0.78 (0.68 to 0.89) | 0.86 (0.78 to 0.94) | 0.96 (0.89 to 1.04) | 0.93 (0.88 to 0.99) | 0.90 (0.76 to 1.07) | 0.72 (0.51 to 1.01) |
| EDITION 2 | 0.53 (0.39 to 0.72) | 0.77 (0.60 to 0.97) | 0.71 (0.58 to 0.86) | 0.78 (0.69 to 0.89) | 0.91 (0.82 to 1.02) | 0.90 (0.83 to 0.98) | 0.77 (0.60 to 0.98) | 0.71 (0.46 to 1.08) |
| EDITION 3 | 0.74 (0.48 to 1.13) | 0.90 (0.67 to 1.22) | 0.76 (0.59 to 0.99) | 0.83 (0.67 to 1.03) | 0.86 (0.74 to 1.00) | 0.88 (0.77 to 1.01) | 0.55 (0.37 to 0.82) | 0.51 (0.27 to 0.94) |
| EDITION 4 | 0.82 (0.70 to 0.96) | 1.06 (0.92 to 1.23) | 0.98 (0.88 to 1.09) | 0.98 (0.92 to 1.04) | 0.98 (0.91 to 1.06) | 1.00 (0.95 to 1.04) | 0.99 (0.88 to 1.11) | 1.05 (0.86 to 1.29) |
| EDITION JP1 | 0.71 (0.56 to 0.91) | 0.84 (0.70 to 1.00) | 0.85 (0.73 to 0.99) | 0.91 (0.84 to 0.99) | 1.01 (0.95 to 1.08) | 0.99 (0.95 to 1.04) | 0.87 (0.75 to 1.00) | 0.64 (0.47 to 0.88) |
| EDITION JP2 | 0.83 (0.45 to 1.52) | 0.58 (0.40 to 0.85) | 0.62 (0.44 to 0.88) | 0.69 (0.52 to 0.91) | 0.84 (0.70 to 1.01) | 0.86 (0.73 to 1.01) | 1.44 (0.67 to 3.10) | 1.17 (0.48 to 2.84) |