Table 4 Summary of safety data (safety analysis set)

Adverse events

46 (64.8)

52.5–75.8

51 (68.0)

56.2–78.3

Adverse drug reactions

16 (22.5)

13.5–34.0

30 (40.0)

28.9–52.0

Serious adverse events

1 (1.4)

0.0–7.6

3 (4.0)

0.8–11.2

Serious adverse drug reactions

0 (0.0)

0.0–5.1

0 (0.0)

0.0–4.8

Adverse events leading to discontinuation

0 (0.0)

0.0–5.1

1 (1.3)

0.0–7.2

Adverse drug reactions leading to discontinuation

0 (0.0)

0.0–5.1

0 (0.0)

0.0–4.8

Deaths

0 (0.0)

0.0–5.1

0 (0.0)

0.0–4.8

AEs of special interest

 Documented hypoglycemia^a

21 (29.6)

30 (40.0)

  Hypoglycemia

15 (21.1)

19 (25.3)

  Blood glucose decreased

11 (15.5)

20 (26.7)

Urinary tract infection

0 (0)

1 (1.3)

 Cystitis

0 (0)

1 (1.3)

Osmotic diuresis

2 (2.8)

4 (5.3)

 Pollakiuria

1 (1.4)

4 (5.3)

 Polyuria

0 (0)

3 (4.0)

 Thirst

1 (1.4)

1 (1.3)

Fracture

1 (1.4)

0 (0)

 Foot Fracture

1 (1.4)

0 (0)

Skin disorder

0 (0)

2 (2.7)

 Seborrheic dermatitis

0 (0)

1 (1.3)

 Urticaria

0 (0)

1 (1.3)

Ketone bodies

2 (2.8)

3 (4.0)

 Blood ketone bodies increased

2 (2.8)

3 (4.0)

(Number of female patients)

(N = 22)

(N = 31)

Vulvovaginitis

0 (0)

1 (3.2)

 Genital candidiasis

0 (0)

1 (3.2)