Table 3.
Self-reported hypoglycemia events in the preceding 4 weeks of the study visit at baseline and after 24 weeks of treatment with insulin detemir
| Measurement | Proportion of patients with at least one event, % (event/person-year) | |||||
|---|---|---|---|---|---|---|
| Age ≤40 years | Age >40–65 years | Age >65 years | ||||
| Baseline | 24 weeks | Baseline | 24 weeks | Baseline | 24 weeks | |
| Hypoglycemia (overall) | ||||||
| Entire cohort | 6.4 (1.89) | 3.3*** (0.91) | 7.3 (2.56) | 4.7*** (1.42) | 10.0 (3.75) | 6.6*** (1.88) |
| n | 1,467 | 1,279 | 10,967 | 9,677 | 2,807 | 2,334 |
| Insulin-experienced | 16.3 (6.40) | 6.3*** (2.16) | 19.9 (7.98) | 6.0*** (1.69) | 23.9 (9.67) | 8.1*** (2.18) |
| n | 258 | 223 | 2,286 | 1,991 | 840 | 680 |
| Insulin-naïve | 4.3 (0.92) | 2.7* (0.65) | 3.9 (1.13) | 4.4 (1.35) | 4.1 (1.22) | 6.0** (1.76) |
| n | 1,209 | 1,056 | 8,681 | 7,686 | 1,967 | 1,654 |
| Sulfonylurea | 6.2 (1.57) | 3.0* (0.87) | 6.0 (1.91) | 4.9 (1.40) | 7.1 (2.69) | 7.1 (2.04) |
| n | 942 | 657 | 8,261 | 5,517 | 1,913 | 1,199 |
| No sulfonylurea | 6.9 (2.45) | 3.5 (0.96) | 11.2 (4.53) | 4.5* (1.44) | 16.3 (6.02) | 6.2** (1.72) |
| n | 525 | 622 | 2,706 | 4,160 | 894 | 1,135 |
| Hypoglycemia (major)a | ||||||
| Entire cohort | 0.8 (0.12) | 0** (0) | 1.1 (0.23) | 0.0*** (0.00) | 1.6 (0.37) | 0.0*** (0.01) |
| Insulin-experienced | 3.5 (0.55) | 0** (0) | 3.5 (0.85) | 0.1*** (0.01) | 4.0 (1.02) | 0.1*** (0.02) |
| Insulin-naïve | 0.2 (0.03) | 0 (0) | 0.4 (0.07) | 0.0*** (0.00) | 0.5 (0.09) | 0** (0) |
| Hypoglycemia (nocturnal)a | ||||||
| Entire cohort | 3.1 (0.53) | 1.0*** (0.26) | 3.5 (0.81) | 1.7*** (0.41) | 4.5 (1.10) | 2.3*** (0.47) |
| Insulin-experienced | 7.4 (1.51) | 2.7* (0.93) | 11.3 (2.84) | 1.7*** (0.42) | 12.3 (3.10) | 2.4*** (0.44) |
| Insulin-naïve | 2.2 (0.32) | 0.7*** (0.12) | 1.5 (0.27) | 1.7 (0.41) | 1.2 (0.25) | 2.2* (0.48) |
Due to the observational nature of this study not all measures were reported or collected
* p < 0.05 for proportion of patients with at least one event at 24 weeks relative to baseline
** p < 0.01 for proportion of patients with at least one event at 24 weeks relative to baseline
*** p < 0.001 for proportion of patients with at least one event at 24 weeks relative to baseline
a n for each cohort same as for hypoglycemia (overall) data