Table 3.
HbA1c, insulin dose and hypoglycaemia summary (0‐12 weeks)
| Subgroups by age | Subgroups by prior insulin use | Subgroups by HbA1c at week 12 | |||||
|---|---|---|---|---|---|---|---|
| <65 y | ≥65 y | Naïve | Not naïve | <7% | 7% to 8.5% | >8.5% | |
| ELEMENT‐2 (N = 756) | |||||||
| Number of patients | n = 542 | n = 214 | n = 457 | n = 299 | n = 288 | n = 367 | n = 45 |
| HbA1c, baseline, % | 8.43 ± 0.05 | 8.07 ± 0.07a | 8.46 ± 0.05 | 8.13 ± 0.06a | 7.81 ± 0.06 | 8.61 ± 0.05a | 9.48 ± 0.14a |
| HbA1c, week 12, % | 7.18 ± 0.05 | 7.23 ± 0.07 | 7.01 ± 0.05 | 7.48 ± 0.06b | 6.48 ± 0.03 | 7.54 ± 0.03b | 9.27 ± 0.07b |
| Insulin dose, week 12, U/kg/d | 0.506 ± 0.02 | 0.400 ± 0.02b | 0.548 ± 0.02 | 0.368 ± 0.02b | 0.429 ± 0.02 | 0.506 ± 0.02b | 0.542 ± 0.04b |
| Rate (events/p/y) | 2.34 ± 0.31 | 3.44 ± 0.61b | 2.75 ± 0.38 | 2.42 ± 0.39 | 2.79 ± 0.45 | 2.54 ± 0.40 | 2.46 ± 0.88 |
| RR (95% CI) | 1.47 (1.04, 2.09) | 0.88 (0.63, 1.23) | Reference | 0.91 (0.64, 1.30) | 0.88 (0.42, 1.83) | ||
| Incidence, n (%) | 154 (28.7) | 77 (36.3)d | 151 (33.5) | 80 (26.8) | 109 (37.8) | 106 (28.9) | 9 (20.0)d |
| Pts with ≥ two events n (%) | 86 (16.0) | 43 (20.3) | 86 (19.1) | 43 (14.4) | 57 (19.8) | 66 (18.0) | 5 (11.1) |
| ELEMENT‐5 (N = 493) | |||||||
| Number of patients | n = 388 | n = 105 | n = 223 | n = 270 | n = 149 | n = 256 | n = 56 |
| HbA1c, baseline, % | 8.65 ± 0.05 | 8.41 ± 0.10a | 8.82 ± 0.07 | 8.43 ± 0.06a | 8.09 ± 0.08 | 8.70 ± 0.06a | 9.58 ± 0.13a |
| HbA1c, week 12, % | 7.42 ± 0.04 | 7.59 ± 0.08 | 7.14 ± 0.06 | 7.71 ± 0.05c | 6.53 ± 0.04 | 7.64 ± 0.03c | 9.12 ± 0.06c |
| Insulin dose, week 12, U/kg/d | 0.550 ± 0.01 | 0.537 ± 0.03 | 0.639 ± 0.02 | 0.474 ± 0.02c | 0.514 ± 0.02 | 0.558 ± 0.02 | 0.618 ± 0.04c |
| Rate (events/p/y) | 0.88 ± 0.19 | 2.11 ± 0.86b | 0.85 ± 0.23 | 1.36 ± 0.34 | 1.70 ± 0.47 | 0.92 ± 0.23 | 0.28 ± 0.15b |
| RR (95% CI) | 2.38 (1.04, 5.46) | 1.60 (0.84, 3.06) | Reference | 0.54 (0.29, 1.01) | 0.16 (0.05, 0.56) | ||
| Incidence, n (%) | 79 (20.5) | 26 (25.2) | 38 (17.2) | 67 (25.0) | 47 (31.5) | 47 (18.4)d | 7 (12.5)d |
| Pts with ≥ two events, n (%) | 29 (7.5) | 12 (11.7) | 15 (6.79) | 26 (9.70) | 18 (12.08) | 18 (7.03) | 2 (3.57) |
Note: Data are given as least square means ± SE unless otherwise indicated.
Abbreviations: BG, blood glucose; CI, confidence interval; p, person; RR, relative rate.
a
P < 0.05 from ANOVA model for differences between subgroups.
b
P < 0.05 from a negative binomial model for differences between subgroups.
c
P < 0.05 (from Fisher's exact test) for differences between subgroups.
d
P < 0.05 (from MMRM model) for differences between subgroups.