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Table 1 Patient demographics and baseline characteristics (full analysis set)

From: Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus

 

Placebo (N = 70)

Canagliflozin 100 mg (N = 76)

Sex, N (%)

 Male

49 (70.0)

44 (57.9)

 Female

21 (30.0)

32 (42.1)

Age (years)

 Mean ± SD

56.1 ± 10.9

59.7 ± 9.4

Duration of diabetes (years)

 Mean ± SD

12.34 ± 8.21

15.18 ± 8.61

Body weight (kg)

 Mean ± SD

69.68 ± 13.13

69.95 ± 13.93

BMI (kg/m2)

 Mean ± SD

25.99 ± 4.40

26.88 ± 4.82

Waist circumference (cm)

 Mean ± SD

90.80 ± 10.97

92.93 ± 11.87

Diabetic complications, N (%)

 All

48 (68.6)

50 (65.8)

 Retinopathy

26 (37.1)

35 (46.1)

 Neuropathy

13 (18.6)

14 (18.4)

 Nephropathy

28 (40.0)

31 (40.8)

Nondiabetic complications, N (%)

 Hypertension

40 (57.1)

48 (63.2)

 Dyslipidemia

49 (70.0)

63 (82.9)

HbA1c (%)

 Mean ± SD

8.85 ± 0.84

8.89 ± 0.81

Fasting plasma glucose (mg/dL)

 Mean ± SD

169.1 ± 52.6

169.9 ± 44.4

Fasting C-peptide (ng/mL)

 Mean ± SD

1.018 ± 0.776

0.959 ± 0.703

HOMA2- %B (%)

 Mean ± SD

24.18 ± 13.84

22.62 ± 11.24

eGFR (mL/min/1.73 m2)

 Mean ± SD

86.1 ± 21.7

83.8 ± 18.4

Daily dose of insulin (unit)

 Mean ± SD

28.1 ± 14.0

31.1 ± 15.1

Daily dose of insulin by insulin regimen (unit)

 Premixed

  N

26

28

  Mean ± SD

29.0 ± 11.6

33.1 ± 14.7

 Intermediate-acting

  N

0

0

  Mean ± SD

–

–

 Long-acting

  N

24

24

  Mean ± SD

20.9 ± 12.2

20.5 ± 12.3

 Premixed + rapid-or short-acting

  N

1

0

  Mean ± SD

16.0

–

Intermediate + rapid-or short-acting

  N

0

0

  Mean ± SD

–

–

 Long-acting + rapid-or short-acting

  N

19

24

  Mean ± SD

36.7 ± 14.9

39.5 ± 12.1

  1. N number of patients, BMI body mass index, HOMA2- %B homeostasis model assessment 2 steady state beta cell function, eGFR, estimated glomerular filtration rate