Table 1.
Patient disposition, demographics and baseline characteristics (safety population)
| Lixisenatide (n = 154) | Placebo (n = 157) | |
|---|---|---|
| Age (mean ± s.d.) (years) | 58.7 ± 10.2 | 58.0 ± 10.1 |
| Male, n (%) | 69 (44.8%) | 80 (51.0%) |
| Race, n (%) | ||
| Asian/Oriental | 154 (100%) | 157 (100%) |
| Japan | 72 (46.8%) | 87 (55.4%) |
| Republic of Korea | 67 (43.5%) | 56 (35.7%) |
| Philippines | 13 (8.4%) | 5 (3.2%) |
| Taiwan | 2 (1.3%) | 9 (5.7%) |
| BMI (mean ± s.d.) (kg/m2) | 25.4 ± 3.7 | 25.2 ± 3.9 |
| Duration of diabetes since diagnosis (mean ± s.d.) (years) | 13.7 ± 7.7 | 14.1 ± 7.7 |
| HbA1c <8%, n (%) | 35 (22.7%) | 36 (22.9%) |
| HbA1c ≥8%, n (%) | 119 (77.3%) | 121 (77.1%) |
| Sulfonylurea use at screening | ||
| Yes | 108 (70.1%) | 111 (70.7%) |
| No | 46 (29.9%) | 46 (29.3%) |
| Duration of treatment with sulfonylurea (mean ± s.d.) (years) | 5.33 ± 4.83 | 6.80 ± 5.24 |
| Insulin use at screening | ||
| Duration of treatment with basal insulin (mean ± s.d.) (years) | 2.94 ± 3.67 | 3.01 ± 4.27 |
| Total daily insulin dose, (mean ± s.d.) (U) | 24.9 ± 14.0 | 24.1 ± 14.2 |
| Glargine [n = 187 (60%)] | 25.1 ± 13.4 | 23.8 ± 12.3 |
| Detemir [n = 83 (27%)] | 19.9 ± 8.7 | 21.2 ± 14.3 |
| NPH [n = 39 (13%)]* | 35.0 ± 20.5 | 28.8 ± 18.2 |
| Premix [n = 2 (<1%)]† | 0 | 48.0 ± 25.5 |
| Efficacy variables at baseline | ||
| HbA1c (mean ± s.d.) (%) | 8.54 ± 0.73 | 8.52 ± 0.78 |
| FPG (mean ± s.d.) (mmol/l) | 7.67 ± 2.32 | 7.75 ± 2.25 |
| 2-h PPG (mean ± s.d.) (mmol/l) | 17.81 ± 3.36 | 17.75 ± 3.94 |
| 2-h glucose excursion (mean ± s.d.) (mmol/l) | 9.72 ± 3.27 | 9.70 ± 4.19 |
| Average 7-point SMPG (mean ± s.d.) (mmol/l) | 11.58 ± 2.51 | 11.42 ± 2.46 |
| Body weight (mean ± s.d.) (kg) | 65.93 ± 13.00 | 65.60 ± 12.47 |
BMI, body mass index; FPG, fasting plasma glucose; HbA1c, glycated haemoglobin; PPG, postprandial plasma glucose; s.d., standard deviation; SMPG, self-monitored plasma glucose.
*
NPH included Isophane insulin and Insulin human injection, isophane.
†
Protocol deviation; Mixed insulin included Novomix.