Table 1.
Pharmacodynamic comparisons for lixisenatide versus placebo
| People with T2DM (n = 20) | Healthy subjects (n = 18) | |||||
|---|---|---|---|---|---|---|
| Placebo | Lixisenatide 20 µg | Geometric mean ratio LIXI/PBO (90% CI) | Placebo | Lixisenatide 20 µg | Geometric mean ratio LIXI/PBO (90% CI) | |
| Insulin response | ||||||
| ISR-AUC0–10 min, pmol/kg | 48 (19) | 133 (49) | 2.8 (2.5, 3.1) | 112 (30) | 268 (78) | 2.4 (2.1, 2.6) |
| ISR-AUC10–120 min,pmol/kg | 593 (158) | 925 (210) | 1.6 (1.4, 1.7) | 370 (111) | 341 (118) | 0.9 (0.8, 1.0) |
| INS-AUC0–10 min,pmol min/l | 503 (385) | 2835 (1778) | 6.6 (5.0, 8.7) | 2620 (1253) | 8269 (3758) | 3.2 (2.7, 3.8) |
| INS-AUC10–120 min,pmol min/l | 10 402 (5158) | 31 602 (17 307) | 3.0 (2.7, 3.3) | 6371 (2327) | 21 885 (8841) | 3.4 (2.7, 4.2) |
| C-peptide response | ||||||
| C-PEP-AUC0–10 min,pmol min/l | 1809 (1432) | 7796 (3990) | 6.1 (4.2, 8.8) | 8661 (3406) | 19 726 (6685) | 2.3 (2.0, 2.7) |
| C-PEP-AUC10–120 min,pmol min/l | 81 555 (25 986) | 167 725 (42 743) | 2.1 (1.9, 2.3) | 65 029 (20 726) | 97 208 (24 858) | 1.5 (1.3, 1.7) |
| Glucose disposal | ||||||
| Glucose disposal, Kglucose,% per min | 0.57 (0.11) | 0.98 (0.11) | 1.8 (1.6, 1.9) | 1.6 (0.8) | 3.8 (1.8) | 2.3 (1.9, 3.0) |
All data are reported as arithmetic mean ± s.d. (standard deviation) unless otherwise stated.
AUC, area under the curve; CI, confidence interval; ISR, insulin secretion rate; ISR-AUC0–10 min, first-phase insulin secretion; ISR-AUC10–120 min, second-phase insulin secretion; INS-AUC0–10 min, first-phase insulin concentration; INS-AUC10–120 min, second-phase insulin concentration; Kglucose, glucose disposal constant; LIXI, lixisenatide; PBO, placebo; T2DM, type 2 diabetes mellitus.