Table 2.
Incidence of hypoglycaemia
| Hypoglycaemia incidence | Gla-300 (N = 4422) | |||
|---|---|---|---|---|
| All hypoglycaemia | Nocturnal hypoglycaemia | |||
| n (%) | Event rate per participant-year, n (rate) | n (%) | Event rate per participant-year, n (rate) | |
| Any hypoglycaemia | ||||
| Month 6 | 64 (1.45) | 81 (0.037) | 10 (0.23) | 13 (0.006) |
| Month 12 | 88 (1.99) | 120 (0.029) | 13 (0.29) | 16 (0.004) |
| Documented symptomatic (blood glucose ≤ 3.9 mmol/L) | ||||
| Month 6 | 38 (0.86) | 60 (0.027) | 8 (0.18) | 10 (0.005) |
| Month 12 | 56 (1.27) | 91 (0.022) | 11 (0.25) | 13 (0.003) |
| Documented symptomatic (blood glucose < 3.0 mmol/L) | ||||
| Month 6 | 5 (0.11) | 5 (0.002) | 2 (0.05) | 2 (0.001) |
| Month 12 | 9 (0.20) | 9 (0.002) | 2 (0.05) | 2 (0.000) |
| Severe hypoglycaemia | ||||
| Month 6 | 5 (0.11) | 6 (0.003) | 1 (0.02) | 1 (0.000) |
| Month 12 | 6 (0.14) | 7 (0.002) | 1 (0.02) | 1 (0.000) |
n (%): number and percentage of participants with at least one hypoglycaemia event
n (rate): number of hypoglycaemia events and event rate per participants-year
The 6-month treatment period was defined as first treatment administration to visit 3 (month 6) or treatment discontinuation, whichever occurred first, and the 12-month treatment period was defined as first treatment administration to visit 4 (month 12) or treatment discontinuation, whichever occurred first
Safety analyses were undertaken in the eligible population (N = 4422; those meeting the inclusion/exclusion criteria who started Gla-300 ± 31 days from study start)
Gla-300 insulin glargine 300 U/mL