Screening demographic data and patient characteristics: randomized population
| Parameters | Insulin glargine with or without metformin plus | ||
|---|---|---|---|
| Lixisenatide 20 µg once daily (n = 298) | Insulin glulisine once daily (n = 298) | Insulin glulisine thrice daily (n = 298) | |
| Age at screening, years | 59.8 ± 8.6 | 60.2 ± 8.6 | 59.4 ± 9.5 |
| Male, n (%) | 138 (46.3) | 135 (45.3) | 132 (44.3) |
| White, n (%) | 276 (92.6) | 280 (94.0) | 272 (91.3) |
| BMI, kg/m2 | 32.3 ± 4.6 | 31.9 ± 4.4 | 32.5 ± 4.6 |
| Body weight, kg | |||
| Start of run-in | 89.8 ± 17.4 | 87.9 ± 15.8 | 89.7 ± 17.3 |
| End of run-in | 90.2 ± 17.5 | 88.4 ± 15.8 | 90.1 ± 17.3 |
| HbA1c, % (mmol/mol) | |||
| Screening | 8.5 ± 0.7 (69 ± 7.7) | 8.5 ± 0.7 (69 ± 7.7) | 8.5 ± 0.8 (69 ± 8.7) |
| End of run-in | 7.9 ± 0.5 (63 ± 5.5) | 7.8 ± 0.5 (62 ± 5.5) | 7.9 ± 0.5 (63 ± 5.5) |
| FPG, mmol/L (mg/dL) | |||
| Start of run-in | 9.2 ± 2.9 (165 ± 53) | 9.3 ± 2.9 (167 ± 52) | 9.5 ± 3.0 (171 ± 53) |
| End of run-in | 6.9 ± 2.1 (125 ± 37) | 6.8 ± 1.8 (122 ± 32) | 6.7 ± 1.9 (119 ± 34) |
| Variables at screening | |||
| Duration of type 2 diabetes, years | 11.9 ± 6.4 | 12.3 ± 6.8 | 12.4 ± 6.8 |
| Duration of basal insulin treatment, years | 3.1 ± 2.6 | 3.3 ± 3.5 | 3.2 ± 3.1 |
| Daily basal insulin dose, units/day | |||
| NPH insulin | 41 ± 20 | 39 ± 18 | 41 ± 20 |
| Insulin glargine | 42 ± 23 | 41 ± 23 | 40 ± 23 |
| Insulin detemir | 41 ± 30 | 40 ± 25 | 39 ± 22 |
| OAD use, n (%) | |||
| Metformin | 262 (87.9) | 260 (87.2) | 259 (86.9) |
| SU | 141 (47.3) | 129 (43.3) | 142 (47.7) |
| DPP-4 inhibitor | 37 (12.4) | 29 (9.7) | 42 (14.1) |
| Insulin glargine dose, units/day | |||
| Start of run-in | 41 ± 22 | 40 ± 22 | 39 ± 21 |
| End of run-in | 68 ± 32 | 65 ± 32 | 65 ± 27 |
| Patients with evening insulin glargine dosing,* % | 73.5 | 76.8 | 73.0 |
| Patients with study drug administration at: | |||
| Breakfast, % | 30.2 | 29.5 | – |
| Evening meal, % | 69.5 | 69.8 | – |
| Missing, % | 0.3 | 0.7 | – |
Data are presented as the mean ± SD or as indicated.
All data are for screening except where indicated otherwise. Start of run-in, week – 12; end of run-in, week – 1.
↵*Data available for 283 lixisenatide-treated patients and 289 patients in each insulin glulisine arm; evening dosing defined as any dose administered between 1600 and 0400 h.