Baseline and 6-week change in HbA1c level, FBG level, body weight, and daily insulin dose during the study
| Lixisenatide | Placebo | P valuea | |
|---|---|---|---|
| Baseline HbA1c (mmol/mol; IFCC) | 61.4 ± 3.0 | 59.9 ± 2.8 | 0.548 |
| Baseline HbA1c (%; DCCT) | 7.7 ± 0.3 | 7.6 ± 0.3 | 0.548 |
| 6-week HbA1c (mmol/mol; IFCC) | 55.6 ± 2.4 | 58.8 ± 2.9 | 0.020 |
| 6-week HbA1c (%; DCCT) | 7.3 ± 0.2 | 7.5 ± 0.3 | 0.020 |
| Change in HbA1c (mmol/mol; IFCC) | −5.8 ± 1.2 (P < 0.001)b | −1.0 ± 1.3 (P = 0.432)b | 0.042 |
| Change in HbA1c (%; DCCT) | −0.5 ± 0.1 (P < 0.001)b | −0.1 ± 0.1 (P = 0.432)b | 0.042 |
| Baseline FBG (mmol/L) | 9.7 ± 0.6 | 9.3 ± 0.7 | 0.547 |
| 6-week FBG (mmol/L) | 8.3 ± 0.6 | 9.3 ± 0.7 | 0.023 |
| Change in FBG (mmol/L) | −1.6 ± 0.4 (P = 0.002)b | 0.0 ± 0.6 (P = 0.986)b | 0.046 |
| Baseline body weight (kg) | 99.5 ± 4.6 | 99.8 ± 4.5 | 0.962 |
| 6-week body weight (kg) | 97.7 ± 4.4 | 99.1 ± 4.4 | 0.823 |
| Change in body weight (kg) | −1.7 ± 0.4 (P < 0.001)b | −0.6 ± 0.4 (P = 0.095)b | 0.043 |
| Baseline daily insulin dose (units) | 39 ± 24 | 39 ± 25 | 0.934 |
| 6-week daily insulin dose (units) | 37 ± 24 | 40 ± 24 | 0.684 |
| Change in daily insulin dose (units) | −1.8 ± 4.1 (P = 0.076)b | 0.8 ± 2.1 (P = 0.135)b | 0.023 |
Data are reported as the mean ± SD, unless otherwise indicated.
↵aP value for the probability level of random difference between the two treatments.
↵bP value for the probability level of random difference before and after treatment within each treatment arm. DCCT, Diabetes Control and Complications Trial unit; IFCC, International Federation of Clinical Chemistry and Laboratory Medicine unit.