Table 2.
Pharmacodynamic outcomes for primary endpoint PPG–AUC0–1 h and secondary endpoint PPG–Cmax
Parameter | Lixisenatide treatment group | Effect estimate vs placebo | 90% confidence intervals | p‐value |
---|---|---|---|---|
PPG–AUC0–1 h (mmol min L−1) | 2.5 µg | −61.2 | −75.2, −47.3 | <0.001 |
5 µg | −92.3 | −106.2, −78.4 | <0.001 | |
10 µg | −118.4 | −132.4, −104.4 | <0.001 | |
20 µg | −121.1 | −135.2, −107.1 | <0.001 | |
PPG–Cmax (mmol L−1) | 2.5 µg | −0.8 | −1.1, −0.5 | <0.001 |
5 µg | −1.0 | −1.3, −0.7 | <0.001 | |
10 µg | −1.5 | −1.8, −1.2 | <0.001 | |
20 µg | −1.2 | −1.6, −0.9 | <0.001 | |
Parameter | Lixisenatide treatment group | Effect estimate between doses | 90% confidence intervals | p‐value |
PPG–AUC0–1 h (mmol min L−1) | 5 µg vs 2.5 µg | −31.1 | −44.7, −17.4 | <0.001 |
10 µg vs 2.5 µg | −57.2 | −70.9, −43.4 | <0.001 | |
20 µg vs 2.5 µg | −59.9 | −73.8, −46.0 | <0.001 | |
10 µg vs 5 µg | −26.1 | −39.8, −12.4 | 0.002 | |
20 µg vs 5 µg | −28.9 | −42.8, −14.9 | <0.001 | |
20 µg vs 10 µg | −2.8 | −16.7, 11.2 | NS | |
PPG–Cmax (mmol L−1) | 5 µg vs 2.5 µg | −0.3 | −0.6, 0.1 | NS |
10 µg vs 2.5 µg | −0.7 | −1.0, −0.4 | <0.001 | |
20 µg vs 2.5 µg | −0.5 | −0.8, −0.2 | 0.015 | |
10 µg vs 5 µg | −0.5 | −0.8, −0.2 | 0.015 | |
20 µg vs 5 µg | −0.2 | −0.6, 0.1 | NS | |
20 µg vs 10 µg | 0.2 | −0.1, 0.6 | NS |
AUC, area under the curve; Cmax, maximum concentration; NS, non‐significant p‐value; PPG, postprandial plasma glucose.
Data are point estimates of treatment group differences with 90% confidence intervals for lixisenatide treatment groups (2.5, 5, 10 and 20 µg) versus placebo or between lixisenatide doses.