Table 3.
Pharmacodynamic outcomes for secondary endpoint INS–AUC0–1 h and INS–Cmax
Parameter | Lixisenatide treatment group | Effect estimate vs placebo | 90% confidence intervals | p‐value |
---|---|---|---|---|
INS–AUC0–1 h (pmol min L−1) | 2.5 µg | −8648 | −12,713, −4584 | <0.001 |
5 µg | −16,762 | −20,848, −12,676 | <0.001 | |
10 µg | −21,896 | −25,936, −17,856 | <0.001 | |
20 µg | −24,848 | −29,078, −20,618 | <0.001 | |
INS–Cmax
(pmol L−1) |
2.5 µg | −101 | −216, 15 | NS |
5 µg | −277 | −391, −164 | <0.001 | |
10 µg | −428 | −543, −314 | <0.001 | |
20 µg | −388 | −509, −268 | <0.001 | |
Parameter | Lixisenatide treatment group | Effect estimate between doses | 90% confidence intervals | p‐value |
INS–AUC0–1 h (pmol min L−1) | 5 µg vs 2.5 µg | −8114 | −12,173, −4055 | 0.001 |
10 µg vs 2.5 µg | −13,248 | −17,214, −9281 | <0.001 | |
20 µg vs 2.5 µg | −16,200 | −20,262, −12,137 | <0.001 | |
10 µg vs 5 µg | −5134 | −9170, −1098 | 0.038 | |
20 µg vs 5 µg | −8086 | −12,322, −3850 | 0.002 | |
20 µg vs 10 µg | −2952 | −7049, 1145 | NS | |
INS–Cmax (pmol L−1) | 5 µg vs 2.5 µg | −177 | −289, −64 | 0.011 |
10 µg vs 2.5 µg | −328 | −440, −216 | <0.001 | |
20 µg vs 2.5 µg | −288 | −403, −173 | <0.001 | |
10 µg vs 5 µg | −151 | −263, −40 | 0.027 | |
20 µg vs 5 µg | −111 | −229, 6 | NS | |
20 µg vs 10 µg | 40 | −76, 156 | NS |
AUC, area under the curve; Cmax, maximum concentration; INS, insulin; NS, non‐significant p‐value.
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.