Table 2.
Baseline values and treatment outcomes at 26 weeks.
| Baseline* | 26 weeks | ||||
|---|---|---|---|---|---|
| Outcome | Glargine (N = 678) | BIL (N = 691) | Glargine (N = 678) | BIL (N = 691) | p |
| HbA1c, %† | 8.47 ± 0.04 | 8.38 ± 0.04 | 6.97 ± 0.04 | 6.76 ± 0.04 | <0.001 |
| Change from baseline | — | — | −1.45 ± 0.04 | −1.66 ± 0.04 | |
| LS mean difference (95% CI) | — | −0.21 (−0.31, −0.11) | |||
| FSG, mmol/l† | 9.1 ± 0.1 | 8.7 ± 0.1 | 7.3 ± 0.1 | 7.0 ± 0.1 | 0.015 |
| Nocturnal hypoglycaemia rate‡ | 0.90 ± 0.08 | 0.84 ± 0.08 | 0.92 ± 0.05 | 0.51 ± 0.03 | <0.001 |
| Nocturnal hypoglycaemia incidence, n (%) | 163 (24.1) | 158 (22.9) | 500 (74.0) | 410 (59.5) | <0.001 |
| Documented symptomatic nocturnal hypoglycaemia rate‡ | 0.30 ± 0.04 | 0.38 ± 0.05 | 0.48 ± 0.04 | 0.24 ± 0.02 | <0.001 |
| Documented symptomatic nocturnal hypoglycaemia incidence, n (%) | 65 (9.6) | 81 (11.8) | 327 (48.4) | 252 (36.6) | <0.001 |
| Total hypoglycaemia rate‡ | 3.58 ± 0.20 | 3.10 ± 0.18 | 5.42 ± 0.19 | 5.97 ± 0.20 | 0.053 |
| Total hypoglycaemia Incidence, n (%) | 390 (57.7) | 374 (54.3) | 653 (96.6) | 656 (95.2) | 0.26 |
| Documented symptomatic hypoglycaemia rate‡ | 1.02 ± 0.09 | 1.14 ± 0.10 | 2.60 ± 0.15 | 2.80 ± 0.16 | 0.34 |
| Documented symptomatic hypoglycaemia incidence, n (%) | 169 (25.0) | 190 (27.6) | 562 (83.1) | 575 (83.5) | 0.95 |
| Daytime hypoglycaemia rate‡ | 2.68 ± 0.17 | 2.26 ± 0.14 | 4.53 ± 0.17 | 5.47 ± 0.20 | <0.001 |
| Daytime hypoglycaemia incidence, n (%) | 340 (50.3) | 327 (47.5) | 643 (95.1) | 651 (94.5) | 0.72 |
| Severe hypoglycaemia rate¶ | 3.59 ± 3.59 | 0 ± 0.0 | 4.72 ± 1.91 | 5.28 ± 1.34 | 0.81 |
| Severe hypoglycaemia incidence, n (%) | 1 (0.1) | 0 (0.0) | 10 (1.5) | 16 (2.3) | 0.15 |
| Anti‐BIL treatment‐emergent antibody response§, n (%) | — | — | 161 (24.0) | 152 (22.3) | 0.33 |
| Systolic blood pressure†, mm Hg | 133 ± 0.6 | 134 ± 0.6 | 135 ± 0.5 | 136 ± 0.5 | 0.51 |
| Diastolic blood pressure†, mm Hg | 77 ± 0.4 | 78 ± 0.4 | 78 ± 0.4 | 78 ± 0.4 | 0.93 |
| Triglycerides†, mmol/l | 1.66 ± 0.04 | 1.69 ± 0.04 | 1.60 ± 0.03 | 1.91 ± 0.03 | <0.001 |
| HDL cholesterol†, mmol/l | 1.24 ± 0.01 | 1.25 ± 0.01 | 1.23 ± 0.01 | 1.20 ± 0.01 | <0.001 |
| LDL cholesterol†, mmol/l | 2.47 ± 0.03 | 2.46 ± 0.03 | 2.56 ± 0.03 | 2.53 ± 0.03 | 0.47 |
| Total cholesterol†, mmol/l | 4.45 ± 0.04 | 4.47 ± 0.04 | 4.52 ± 0.03 | 4.58 ± 0.03 | 0.14 |
| ALT†, IU/l | 27.8 ± 0.6 | 27.8 ± 0.5 | 27.2 ± 0.5 | 35.4 ± 0.5 | <0.001 |
| AST†, IU/l | 24.1 ± 0.4 | 24.7 ± 0.4 | 24.3 ± 0.4 | 28.7 ± 0.4 | <0.001 |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BIL, basal insulin peglispro; FSG, fasting serum glucose; HbA1c, glycated haemoglobin; s.e., standard error.
*
Baseline values were not significantly different between groups (p > 0.05), except for FSG (p = 0.026).
†
Least squares mean ± s.e.
¶
Events/patient/100 years; aggregated rate ± standard deviation.
‡
Events/patient/30 days; group mean ± s.e.
§
Treatment‐emergent antibody response defined as change from baseline to post‐baseline in the anti‐BIL antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline.