TABLE 1.
Baseline demographics and disease characteristics by treatment group
| Characteristic | Lixisenatide (N = 18) | Placebo (N = 5) |
|---|---|---|
| Age, years | ||
| Mean ± SD | 15.6 ± 1.0 | 15.4 ± 1.5 |
| Range | 14, 17 | 13, 17 |
| Duration of diabetes, years | ||
| Mean ± SD | 1.6 ± 1.2 | 3.5 ± 2.2 |
| Range | 0, 5 | 0, 6 |
| Age at diabetes onset, years | ||
| Mean ± SD | 14.3 ± 1.2 | 11.7 ± 3.1 |
| Range | 13, 17 | 8, 16 |
| Sex, female, n (%) | 13 (72.2) | 3 (60.0) |
| Race, n (%) | ||
| White | 12 (66.7) | 4 (80.0) |
| Black | 4 (22.2) | 0 |
| Asian | 0 | 0 |
| Other | 2 (11.1) | 1 (20.0) |
| Weight, kg | ||
| Mean ± SD | 91.3 ± 18.8 | 98.0 ± 14.7 |
| Range | 61, 123 | 88, 123 |
| BMI, kg/m2 | ||
| Mean ± SD | 33.2 ± 4.8 | 37.4 ± 3.6 |
| Range | 24, 42 | 34, 42 |
| HbA1c, % (mmol/mol) | ||
| Mean ± SD | 8.16 ± 0.93 | 8.14 ± 1.58 |
| (65.7 ± 10.2) | (65.4 ± 17.3) | |
| Range | 6.7, 10.3 | 6.8, 9.9 |
| (50, 89) | (51, 85) | |
| FPG, mmol/L | ||
| Mean ± SD | 9.6 ± 3.1 | 7.1 ± 2.2 |
| Range | 5.3, 16.5 | 4.7, 10.1 |
| Creatinine clearance, mL/min/1.73 m2 | ||
| Mean ± SD | 107.6 ± 17.0 | 129.8 ± 28.7 |
| Range | 81, 143 | 84, 157 |
| Background treatment at screening, n (%) | ||
| Metformin only | 13 (72.2) | 3 (60.0) |
| Basal insulin only | 1 (5.6) | 0 |
| Metformin + basal insulin | 4 (22.2) | 2 (40.0) |
Abbreviations: BMI, body mass index; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; SD, standard deviation.