Table 1.
Demographics and characteristics at screening or baseline of the 30-week completers of the LixiLan-L trial (30-week completers from the modified intent-to-treat population)
| Demographics and clinical characteristics | iGlarLixi | iGlar | ||||||
|---|---|---|---|---|---|---|---|---|
| All completers | HbA1c ≤ 8% | 8% < HbA1c ≤ 9% | HbA1c > 9% | All completers | HbA1c ≤ 8% | 8% < HbA1c ≤ 9% | HbA1c > 9% | |
| (n = 327) | (n = 97) | (n = 161) | (n = 69) | (n = 333) | (n = 94) | (n = 158) | (n = 81) | |
| Age (years) | 59.5 ± 9.4 | 60.7 ± 9.5 | 59.1 ± 9.8 | 58.6 ± 8.2 | 60.5 ± 8.4 | 61.4 ± 7.8 | 59.9 ± 8.1 | 60.7 ± 9.6 |
| Female (%) | 55.4 | 52.6 | 57.1 | 55.1 | 52.6 | 51.1 | 51.9 | 55.6 |
| Duration of T2D (years) | 12.1 ± 6.7 | 11.9 ± 6.8 | 11.6 ± 6.1 | 13.7 ± 7.7 | 12.1 ± 6.9a | 12.7 ± 7.1a | 11.8 ± 6.5 | 11.9 ± 7.5 |
| Screening BMI (kg/m2) | 31.7 ± 4.2 | 31.4 ± 4.1 | 32.0 ± 4.3 | 31.3 ± 4.2 | 31.1 ± 4.2 | 31.0 ± 4.3 | 31.1 ± 4.3 | 31.4 ± 4.2 |
| Screening HbA1c (%) | 8.47 ± 0.65a | 7.78 ± 0.18 | 8.47 ± 0.29a | 9.45 ± 0.29 | 8.52 ± 0.66a | 7.77 ± 0.16 | 8.49 ± 0.28a | 9.46 ± 0.28a |
| Baseline HbA1c (%) | 8.04 ± 0.67a | 7.74 ± 0.58 | 8.05 ± 0.67a | 8.42 ± 0.60 | 8.05 ± 0.72a | 7.62 ± 0.55 | 8.10 ± 0.67a | 8.45 ± 0.75a |
| Basal insulin dose at run-in (U/day) | 28 ± 8 | 29 ± 8 | 28 ± 8 | 28 ± 8 | 29 ± 8 | 28 ± 8 | 29 ± 8 | 30 ± 8 |
| iGlar dose at randomization (U/day) | 35 ± 9 | 35 ± 9 | 35 ± 10 | 35 ± 9 | 35 ± 9 | 34 ± 8 | 36 ± 9 | 35 ± 7 |
All data are presented as the mean ± standard deviation (SD) unless stated otherwise
BMI Body mass index, HbA 1c glycated hemoglobin, iGlar insulin glargine U100, iGlarLixi fixed-ratio combination of insulin glargine + lixisenatide, T2D type 2 diabetes
aNumbers (n) differed for the duration of T2D in those receiving iGlar (all completers: n = 332; HbA1c ≤ 8% subcategory: n = 93) and for screening and baseline HbA1c for those receiving iGlarLixi (all completers: n = 325; 8% < HbA1c ≤ 9% subcategory: n = 159) and iGlar (all completers: n = 331; 8% < HbA1c ≤ 9% subcategory: n = 157; HbA1c > 9% subcategory: n = 80)