Table 1.
Baseline demographics and treatment characteristics in the East and Southeast (E/SE) Asian population (all subjects as treated population)
| Placebo pool | Active comparator study | Broad pool | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 55) | Ertugliflozin 5 mg (n = 55) | Ertugliflozin 15 mg (n = 51) | Glimepiride (n = 56) | Ertugliflozin 5 mg (n = 54) | Ertugliflozin 15 mg (n = 64) | Non‐ertugliflozin (n = 135) | Ertugliflozin 5 mg (n = 155) | Ertugliflozin 15 mg (n = 165) | |
| Male, n (%) | 30 (54.5) | 28 (50.9) | 28 (54.9) | 26 (46.4) | 22 (40.7) | 29 (45.3) | 69 (51.1) | 70 (45.2) | 75 (45.5) |
| Age (years) | 57.0 (9.9) | 57.6 (10.2) | 57.5 (9.3) | 56.9 (9.1) | 56.6 (9.5) | 53.6 (10.8) | 56.4 (9.9) | 56.1 (10.5) | 55.7 (10.0) |
| Duration of type 2 diabetes mellitus, years | 9.1 (5.1) | 9.3 (6.9) | 9.4 (4.8) | 7.6 (6.0) | 7.6 (6.1) | 6.3 (5.7) | 7.9 (5.4) | 8.0 (6.3) | 7.9 (5.9) |
| Body weight, kg | 69.8 (11.4) | 69.4 (15.3) | 71.3 (11.8) | 64.6 (13.2) | 69.3 (12.4) | 68.9 (12.4) | 67.5 (12.9) | 69.8 (15.6) | 68.9 (12.5) |
| BMI, kg/m2 | 26.3 (4.1) | 26.1 (4.4) | 26.7 (3.1) | 25.3 (3.4) | 26.9 (4.1) | 26.6 (3.8) | 26.1 (4.2) | 26.9 (4.7) | 26.8 (3.8) |
| HbA1c, % |
n = 54 8.2 (0.9) |
n = 55 8.1 (0.9) |
n = 50 8.0 (0.9) |
n = 56 7.8 (0.6) |
n = 54 7.7 (0.5) |
n = 64 7.9 (0.7) |
n = 133 8.1 (0.9) |
n = 152 8.1 (0.9) |
n = 163 8.2 (0.9) |
| FPG, mg/dL |
n = 54 155.6 (26.9) |
n = 55 158.7 (29.8) |
n = 50 158.6 (36.7) |
n = 56 145.1 (25.3) |
n = 54 147.1 (24.0) |
n = 64 155.8 (37.3) |
n = 134 153.7 (30.1) |
n = 155 153.9 (30.1) |
n = 163 157.1 (38.5) |
| SBP, mmHg |
n = 55 127.6 (14.4) |
n = 55 127.7 (11.4) |
n = 51 127.2 (12.8) |
n = 56 127.4 (12.3) |
n = 54 126.7 (12.6) |
n = 64 129.2 (11.1) |
n = 133 128.0 (13.1) |
n = 151 128.3 (12.2) |
n = 162 128.2 (11.8) |
| eGFR, mL/min/1.73 m2 |
n = 55 93.9 (18.0) |
n = 55 88.3 (18.0) |
n = 51 93.4 (21.4) |
n = 56 92.4 (17.4) |
n = 54 96.1 (24.0) |
n = 64 92.9 (17.6) |
n = 135 90.9 (19.4) |
n = 155 89.2 (24.3) |
n = 165 88.2 (22.6) |
| Enrolment region | |||||||||
| Asia | 55 (100) | 55 (100) | 51 (100) | 56 (100) | 54 (100) | 64 (100) | 135 (100) | 155 (100) | 165 (100) |
| Background AHA therapya, n (%) | |||||||||
| Currently on AHA therapy | 55 (100) | 55 (100) | 51 (100) | 56 (100) | 54 (100) | 63 (98.4)b | 134 (99.3) | 153 (98.7) | 162 (98.2) |
| Biguanides | 55 (100) | 55 (100) | 51 (100) | 56 (100) | 54 (100) | 64 (100) | 128 (94.8) | 139 (89.7) | 148 (89.7) |
| DPP4 inhibitors | 26 (47.3) | 22 (40.0) | 21 (41.2) | 0 (0) | 0 (0) | 2 (3.1) | 32 (23.7) | 35 (22.6) | 30 (18.2) |
| Sulphonylurea | 15 (27.3) | 19 (34.5) | 13 (25.5) | 6 (10.7) | 11 (20.4) | 7 (10.9) | 3 (2.2) | 11 (7.1) | 8 (4.8) |
| Other blood glucose‐lowering agents | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 4 (3.0) | 3 (1.9) | 7 (4.2) |
| Number of AHA agentsa, n (%) | |||||||||
| 1 | 14 (25.5) | 14 (25.5) | 17 (33.3) | 50 (89.3) | 43 (79.6) | 55 (85.9) | 102 (75.6) | 118 (76.1) | 131 (79.4) |
| 2 | 41 (74.5) | 41 (74.5) | 34 (66.7) | 6 (10.7) | 11 (20.4) | 9 (14.1) | 31 (23.0) | 35 (22.6) | 31 (18.8) |
| ≥3 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.7) | 0 (0) | 0 (0) |
Abbreviations: AHA, antihyperglycaemic agent; BMI, body mass index; DPP4, dipeptidyl peptidase‐4; eGFR, estimated glomerular filtration rate;
FPG, fasting plasma glucose; SBP, systolic blood pressure.
Data are mean (SD) unless otherwise stated.
At screening for the placebo pool and active comparator study or at randomization for the broad pool.
One patient was reported in the category of “not on an AHA” at screening; however, this patient was taking metformin at screening.