Table 1

Baseline demographic and clinical characteristics—safety population

CharacteristicITCA 650 40 μg/day (n = 153)ITCA 650 60 μg/day (n = 153)Placebo (n = 154)
Age, years55.5 ± 10.354.7 ± 9.654.7 ± 9.1
Female sex64 (41.8)62 (40.5)62 (40.3)
Race
 White129 (84.3)125 (81.7)126 (81.8)
 Black or African American20 (13.1)21 (13.7)23 (14.9)
 Other4 (2.6)7 (4.6)5 (3.3)
Hispanic or Latino56 (36.6)47 (30.7)59 (38.3)
Duration of diabetes, years9.1 ± 6.28.9 ± 6.98.6 ± 6.0
Body weight, kg96.8 ± 18.697.6 ± 18.398.2 ± 21.9
BMI, kg/m233.1 ± 5.133.8 ± 5.233.7 ± 5.5
HbA1c, % [mmol/mol]8.5 ± 0.8 [69.5 ± 8.5]8.5 ± 0.8 [68.8 ± 8.6]8.5 ± 0.8 [69.9 ± 9.1]
FPG, mmol/L (mg/dL)11.0 ± 2.7 (198.2 ± 48.6)10.3 ± 2.6 (185.6 ± 46.8)10.9 ± 2.8 (196.4 ± 50.5)
eGFR, mL/min/BSA86.5 ± 19.287.6 ± 17.689.3 ± 19.2
Heart rate, bpm74.9 ± 10.075.3 ± 10.074.7 ± 10.9
Systolic BP, mmHg133.9 ± 14.6131.6 ± 14.4132.7 ± 15.1
Diastolic BP, mmHg81.0 ± 8.780.5 ± 8.381.0 ± 8.5
Medications at baseline137 (89.5)135 (88.2)138 (89.6)
 Metformin monotherapy63 (41.2)61 (39.9)66 (42.9)
 SU monotherapy7 (4.6)7 (4.6)2 (1.3)
 Metformin + SU61 (39.9)65 (42.5)64 (41.6)
 Metformin + SU + TZD4 (2.6)1 (0.7)6 (3.9)
  • Data are mean ± SD or n (%). BSA, body surface area; TZD, thiazolidinedione.

  • †One (0.7%) patient in the ITCA 650 60 μg/day group was taking TZD + metformin as background therapy.