Baseline demographics and clinical characteristics (randomized population)
| iGlarLixi (n = 469) | iGlar (n = 467) | Lixi (n = 234) | All (N = 1,170) | |
|---|---|---|---|---|
| Age (years) | 58.2 ± 9.5 | 58.3 ± 9.4 | 58.7 ± 8.7 | 58.4 ± 9.3 |
| Sex | ||||
| Male | 222 (47.3) | 237 (50.7) | 133 (56.8) | 592 (50.6) |
| Female | 247 (52.7) | 230 (49.3) | 101 (43.2) | 578 (49.4) |
| Race | ||||
| Caucasian | 417 (88.9) | 421 (90.1) | 216 (92.3) | 1,054 (90.1) |
| Black | 33 (7.0) | 33 (7.1) | 12 (5.1) | 78 (6.7) |
| Asian/Oriental | 8 (1.7) | 7 (1.5) | 3 (1.3) | 18 (1.5) |
| Other | 11 (2.3) | 6 (1.3) | 3 (1.3) | 20 (1.7) |
| Ethnicity | ||||
| Hispanic | 85 (18.1) | 87 (18.6) | 51 (21.8) | 223 (19.1) |
| Non-Hispanic | 384 (81.9) | 380 (81.4) | 183 (78.2) | 947 (80.9) |
| Duration of diabetes (years) | 8.9 ± 5.5 | 8.7 ± 5.6 | 8.9 ± 6.3 | 8.8 ± 5.7 |
| Baseline BMI (kg/m2) | 31.6 ± 4.4 | 31.7 ± 4.5 | 32.0 ± 4.4 | 31.7 ± 4.4 |
| Patients with BMI ≥30 kg/m2 | 62.9 | 61.7 | 67.9 | 63.4 |
| HbA1c at screening | ||||
| % | 8.2 ± 0.7 | 8.2 ± 0.7 | 8.3 ± 0.7 | 8.2 ± 0.7 |
| mmol/mol | 66 | 66 | 67 | 66 |
| HbA1c at baseline | ||||
| % | 8.1 ± 0.7 | 8.1 ± 0.7 | 8.1 ± 0.7 | 8.1 ± 0.7 |
| mmol/mol | 65 | 65 | 65 | 65 |
| Patients with HbA1c ≥8% (64 mmol/mol) | 55.9 | 55.7 | 56.0 | 55.8 |
| Baseline FPG (mmol/mol) | 9.9 ± 2.4 | 9.8 ± 2.3 | 9.8 ± 2.2 | 9.8 ± 2.3 |
| Baseline metformin dose (mg) | 2,246 ± 457 | 2,245 ± 445 | 2,267 ± 427 | 2,250 ± 446 |
| Second oral glucose-lowering therapy use at screening | ||||
| Yes | 58.4 | 57.8 | 56.8 | 57.9 |
| Sulfonylurea | 55.2 | 53.3 | 52.6 | 53.9 |
| Glinide | 0.6 | 2.1 | 2.1 | 1.5 |
| SGLT-2 inhibitor | 0.4 | 0.4 | 0 | 0.3 |
| DPP-4 inhibitor | 2.6 | 2.4 | 2.1 | 2.4 |
Data are mean ± SD, n (%), or %. Screening values are at week −6; baseline values are at week −1. DPP-4, dipeptidyl peptidase 4; SGLT-2, sodium-glucose cotransporter 2.