TABLE 1.
Characteristic | Imeglimin (N = 30) | Placebo (N = 29) | Overall (N = 59) |
---|---|---|---|
Age (years) | 58.4 (8.0) | 54.3 (8.9) | 56.4 (8.6) |
Gender | |||
Male | 12 (40.0%) | 16 (55.2%) | 28 (47.5%) |
Female | 18 (60.0%) | 13 (44.8%) | 31 (52.5%) |
Ethnic Origin: Not Hispanic or Latino | 30 (100%) | 29 (100%) | 59 (100%) |
Race: White | 30 (100%) | 29 (100%) | 59 (100%) |
Weight (kg) | 90.83 (16.10) | 93.21 (17.00) | 92.00 (16.45) |
BMI (kg/m2) | 32.83 (4.95) | 32.91 (4.26) | 32.87 (4.58) |
eGFR (MDRD, ml/min/1.73 m2) | 97.5 (19.0) | 99.7 (20.1) | 98.6 (19.4) |
Duration of diabetes (years) | 5.9 (4.5) | 5.0 (2.8) | 5.4 (3.8) |
Metformin daily dose (mg) | 2040.0 (338.7) | 2037.9 (364.9) | 2039.0 (348.8) |
HbA1c (%) | |||
At screening (before washout) | 7.74 (0.47) | 7.86 (0.60) | 7.80 (0.54) |
At randomization (baseline) | 8.12 (0.56) | 8.14 (0.61) | 8.13 (0.58) |
Fasting plasma glucose (mmol/L) | 11.33 (2.53) | 10.25 (1.92) | 10.80 (2.99) |
Note: Data are reported as mean (SD) or n (%).
Abbreviations: BMI, body mass index; eGFR, estimated glomerular filtration rate; For HbA1c and FPG, n, 29 and 28, respectively (ITT pop); HbA1c, glycated haemoglobin; MDRD, modified diet in renal disease; SD, standard deviation.