TABLE 3.
Pharmacodynamic and other outcomes at Day 42, following administration of maximum lixisenatide dose (20 μg) for 14 days, presented by treatment group (PD population)
| Lixisenatide N = 18 | Placebo N = 5 | |
|---|---|---|
| HbA1c, % | ||
| Baseline | 8.2 ± 0.9 (6.7, 10.3) | 8.1 ± 1.6 (6.8, 9.9) |
| Day 42 | 7.9 ± 1.3 (5.7, 10.3) | 8.2 ± 1.1 (6.6, 9.5) |
| Change from baseline | −0.3 ± 1.2 (−3.3, 2.5) | 0.1 ± 1.1 (−1.4, 1.1) |
| HbA1c, mmol/mol | ||
| Baseline | 66 ± 10 (50, 89) | 65 ± 17 (51, 85) |
| Day 42 | 63 ± 14 (39, 89) | 66 ± 12 (49, 80) |
| Change from baseline | –3 ± 13 (−36, 27) | 1 ± 12 (−15, 12) |
| BMI, kg/m2 | ||
| Baseline | 33.2 ± 4.8 (24, 42) | 37.4 ± 3.6 (34, 42) |
| Day 42 | 33.4 ± 5.2 (24, 44) | 38.4 ± 4.0 (34, 42) |
| Change from baseline | 0.2 ± 0.6 (−1, 2) | 1.0 ± 0.9 (0, 3) |
| BMI percentile | ||
| Baseline | 98.28 ± 3.55 (86.30, 99.99) | 99.88 ± 0.14 (99.66, 99.98) |
| Day 42 | 98.07 ± 4.10 (84.19, 99.99) | 99.90 ± 0.12 (99.72, 99.99) |
| Change from baseline | −0.21 ± 0.56 (−2.11, 0.17) | 0.02 ± 0.03 (0.00, 0.06) |
| Body weight, kg | ||
| Baseline | 91.3 ± 18.8 (61.1, 123.0) | 98.0 ± 14.7 (88.4, 123.0) |
| Day 42 | 92.0 ± 19.7 (60.2, 123.2) | 100.8 ± 17.5 (90.0, 131.0) |
| Change from baseline | 0.7 ± 1.8 (−1.6, 5.0) | 2.8 ± 3.0 (0.9, 8.0) |
| FPG, mmol/L | ||
| Baseline | 9.6 ± 3.1 (5.3, 16.5) | 7.1 ± 2.2 (4.7, 10.1) |
| Day 42 | 8.4 ± 2.0 (4.9, 11.3) | 10.0 ± 3.6 (6.5, 16.0) |
| Change from baseline | −1.2 ± 2.1 (−6.2, 2.5) | 2.9 ± 3.7 (−0.3, 9.2) |
| Estimated treatment difference (95% CI); p‐value | −4.2 (−6.8, −1.6); p = 0.0030 | |
| Glucose AUC0–4.5, mmol·h/L | ||
| Baseline | 55.2 ± 16.9 (24.6, 85.2) | 44.0 ± 13.5 (32.1, 62.4) |
| Day 42 | 38.7 ± 10.7 (19.6, 62.6) | 57.8 ± 17.5 (40.4, 84.8) |
| Change from baseline | −17.3 ± 12.2 (−40.3, 9.0) | 13.8 ± 18.9 (0.5, 46.5) |
| Estimated treatment difference (95% CI); p‐value | −31.2 (−46.3, −16.1); p = 0.0004 | |
| 2‐hr PPG excursion, mmol/L | ||
| Baseline | 4.0 ± 2.5 (−0.2, 7.8) | 4.2 ± 3.0 (2.5, 9.5) |
| Day 42 | 0.1 ± 2.4 (−2.9, 6.3) | 4.1 ± 2.1 (2.6, 7.7) |
| Change from baseline | −4.0 ± 3.2 (−9.9, 1.1) | −0.1 ± 1.2 (−1.8, 1.4) |
| Estimated treatment difference (95% CI); p‐value | −3.9 (−6.8, −0.9); p = 0.0121 | |
Note: Data are presented as mean ± SD (range), unless otherwise stated.
Abbreviations: AUC0–4.5, area under the curve from 0 h to 4.5 h; BMI, body mass index; CI, confidence interval; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; PD, pharmacodynamic; PPG, post‐prandial glucose; SD, standard deviation.