Table 3.
Safety outcomes before and after 24 weeks of treatment with biphasic insulin aspart 30 by age-group
| Measurement | ≤40 years | >40–65 years | >65 years | |||
|---|---|---|---|---|---|---|
| Baseline | 24 weeks | Baseline | 24 weeks | Baseline | 24 weeks | |
| Overall hypoglycemia, % patients with at least one event (event/person-year) | ||||||
| Entire cohort | 7.3 (2.27) | 4.4*** (1.06) | 7.3 (2.26) | 5.4*** (1.39) | 9.2 (3.17) | 7.9** (2.11) |
| n | 4,347 | 3,620 | 29,036 | 25,134 | 6,739 | 5,688 |
| Insulin-experienced | 16.2 (6.54) | 8.9*** (2.19) | 14.9 (5.15) | 8.3*** (2.22) | 16.2 (5.99) | 10.3*** (2.90) |
| n | 1,109 | 868 | 8,998 | 7,712 | 2,943 | 2,502 |
| Insulin-naïve | 4.2 (0.80) | 3.0* (0.71) | 3.9 (0.96) | 4.1 (1.02) | 3.8 (0.99) | 6.1*** (1.49) |
| n | 3,238 | 2,752 | 20,038 | 17,422 | 3,796 | 3,186 |
| Sulfonylurea | 5.5 (1.20) | 1.0*** (0.16) | 5.3 (1.43) | 2.2*** (0.46) | 6.5 (2.00) | 4.8 (0.92) |
| n | 1,967 | 1,041 | 16,095 | 6,555 | 2,948 | 875 |
| Non-sulfonylurea | 8.8 (3.15) | 5.8 (1.43) | 9.9 (3.29) | 6.6*** (1.72) | 11.3 (4.08) | 8.5* (2.33) |
| n | 2,380 | 2,579 | 12,941 | 18,579 | 3,791 | 4,813 |
| Major hypoglycemia, % patients with at least one event (event/person-year) | ||||||
| Entire cohort | 1.2 (0.25) | 0.0*** (0.00) | 1.1 (0.20) | 0.0*** (0.01) | 1.6 (0.35) | 0.1*** (0.03) |
| n | 4,347 | 3,620 | 29,036 | 25,134 | 6,739 | 5,688 |
| Insulin-experienced | 4.2 (0.89) | 0*** (0) | 2.4 (0.45) | 0.1*** (0.01) | 2.7 (0.60) | 0.2*** (0.06) |
| n | 1,109 | 868 | 8,998 | 7,712 | 2,943 | 2,502 |
| Insulin-naïve | 0.2 (0.03) | 0.0 (0.01) | 0.5 (0.08) | 0.0*** (0.00) | 0.8 (0.15) | 0*** (0) |
| n | 3,238 | 2,752 | 20,038 | 17,422 | 3,796 | 3,186 |
| Nocturnal hypoglycemia, % patients with at least one event (event/person-year) | ||||||
| Entire cohort | 3.2 (0.63) | 1.2*** (0.20) | 3.1 (0.65) | 1.5*** (0.29) | 3.6 (0.93) | 2.6*** (0.52) |
| n | 4,347 | 3,620 | 29,036 | 25,134 | 6,739 | 5,688 |
| Insulin-experienced | 8.0 (1.78) | 3.3*** (0.51) | 6.6 (1.51) | 2.5*** (0.49) | 6.6 (1.72) | 3.8*** (0.76) |
| n | 1,109 | 868 | 8,998 | 7,712 | 2,943 | 2,502 |
| Insulin-naïve | 1.5 (0.24) | 0.5*** (0.10) | 1.5 (0.27) | 1.1*** (0.20) | 1.3 (0.32) | 1.6 (0.33) |
| n | 3,238 | 2,752 | 20,038 | 17,422 | 3,796 | 3,186 |
| Body weight (SD), kg | ||||||
| Entire cohort | 70.8 (13.5) | 71.1*** (13.0) | 72.3 (13.6) | 72.5*** (13.0) | 69.5 (13.4) | 70.1*** (12.9) |
| n | 3,182 | 21,757 | 4,873 | |||
| Insulin-experienced | 72.9 (15.5) | 73.2* (15.1) | 75.8 (15.0) | 75.9* (14.5) | 72.0 (14.3) | 72.3*** (14.0) |
| n | 747 | 6,751 | 2,136 | |||
| Insulin-naïve | 70.2 (12.8) | 70.4** (12.3) | 70.7 (12.6) | 70.9*** (12.0) | 67.5 (12.3) | 68.5*** (11.7) |
| n | 2,435 | 15,006 | 2,737 | |||
Due to the non-interventional nature of this study, not all baseline data were recorded and some patients were lost to follow-up
*** p < 0.001 vs. baseline
** p < 0.01 vs. baseline
* p < 0.05 vs. baseline