Number of patients (%)

Safety analysis population (n = 2602)

Efficacy analysis population (n = 1629)

Sex

Male

1566 (60.2)

1022 (62.7)

Female

1036 (39.8)

607 (37.3)

Age (mean, years)^a)

62.6

61.8

Weight (mean, kg)^a)

64.6

65.7

BMI (mean, kg/m²)^a)b)

24.8

25.0

Duration of diabetes (years)^a)

<1

70 (2.7)

49 (3.0)

≥1, <5

315 (12.1)

212 (13.0)

≥5, <10

448 (17.2)

305 (18.7)

≥10, <15

493 (19.0)

318 (19.5)

≥15

720 (27.7)

389 (23.9)

Unknown/not specified

556 (21.4)

356 (21.9)

Complications

Diabetic nephropathy

624 (24.0)

367 (22.5)

Diabetic retinopathy

412 (15.8)

237 (14.6)

Diabetic neuropathy

430 (16.5)

243 (14.9)

Hypertension

1311 (50.4)

778 (47.8)

Dyslipidaemia

1376 (52.9)

846 (51.9)

Ischemic heart disease

179 (6.9)

91 (5.6)

Ischemic cerebrovascular disease

129 (5.0)

71 (4.4)

Peripheral arterial occlusive disease

105 (4.0)

56 (3.4)

Laboratory values^c)

HbA1c (mean, %)^b)

9.35

9.58

FPG (mean, mg/dL)^b)

198.1

204.6

2h-PPG (mean, mg/dL)^b)

263.4

272.8

Fasting plasma CPR (mean, ng/mL)^b)

1.97

2.14

e-GFR (mean, mL/min/1.73 m²)^b)

79.0

81.2

Treatment regimen

Anti-diabetes drugs regimen at baseline

Basal-bolus ± OAD^b)

177 (6.8)

0 (0.0)

Basal only

93 (3.6)

0 (0.0)

BOT

2270 (87.2)

1629 (100.0)

Number of OAD: 1

744 (28.6)

477 (29.3)

Number of OAD: 2

786 (30.2)

566 (34.8)

Number of OAD: 3

558 (21.5)

438 (26.9)

Number of OAD: ≥4

182 (7.0)

148 (9.1)

Others

62 (2.4)

0 (0.0)