Safety analysis population (n = 2602)

Efficacy analysis population (n = 1629)

Number of patients

2602

1629

Number of patients with adverse drug reactions

14

8

Number of cases of adverse drug reactions

15

9

Incidence (%) of adverse drug reactions

0.54%

0.49%

Types of adverse drug reactions

Incidence of serious adverse drug reactions by type number of patients (%)

Metabolism and nutrition disorders

9 (0.35)

4 (0.25)

Inadequate glycaemic control

1 (0.04)

0 (0.00)

Hypoglycaemia

8 (0.31)

4 (0.25)

Nervous system disorders

1 (0.04)

1 (0.06)

Hypoglycaemic seizure

1 (0.04)

1 (0.06)

Hypoglycaemic unconsciousness

1 (0.04)

1 (0.06)

Eye disorders

1 (0.04)

1 (0.06)

Diabetic retinopathy

1 (0.04)

1 (0.06)

General disorders and administration site conditions

1 (0.04)

1 (0.06)

Death^*

1 (0.04)

1 (0.06)

Laboratory tests

2 (0.08)

1 (0.06)

Blood glucose level increased

2 (0.08)

1 (0.06)