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Table 3 Effect of canagliflozin on secondary endpoints

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

Parameters

Placebo

Canagliflozin 100 mg

FPG (mg/dL)

 N

70

75

 Mean (SD) baseline

169.1 (52.6)

170.6 (44.4)

 LS mean (SE) changea

−1.4 (5.0)

−34.1 (4.8)

 Difference (95 % CI) vs placebo

–

−32.6 (−46.3, −18.9)

 p value

–

<0.001

Body weight (kg)

 N

70

75

 Mean (SD) baseline

69.68 (13.13)

70.19 (13.86)

 LS mean (SE) changea

0.15 (0.18)

−1.49 (0.18)

(%)

 LS mean (SE) percent changea

0.24 (0.26)

−2.13 (0.25)

 Difference (95 % CI) vs placebo

–

−2.37 (−3.09, −1.65)

 p value

–

<0.001

SBP (mmHg)

 N

70

76

 Mean (SD) baseline

129.95 (16.32)

136.85 (12.01)

 LS mean (SE) changea

−0.40 (1.19)

−3.58 (1.14)

 Difference (95 % CI) vs placebo

–

−3.19 (−6.49, 0.11)

 p value

–

0.058

DBP (mmHg)

 N

70

76

 Mean (SD) baseline

77.23 (10.87)

78.34 (10.18)

 LS mean (SE) changea

−0.31 (0.74)

−1.55 (0.71)

 Difference (95 % CI) vs placebo

–

−1.24 (−3.27, 0.80)

 p value

–

0.232

Triglyceride (mg/dL)

 N

70

75

 Mean (SD) baseline

144.0 (114.0)

124.5 (112.3)

 LS mean (SE) changea

−4.0 (7.7)

−7.8 (7.4)

 Difference (95 % CI) vs placebo

–

−3.8 (−25.0, 17.3)

 p value

–

0.721

HDL-cholesterol (mg/dL)

 N

70

75

 Mean (SD) baseline

57.6 (16.9)

61.9 (16.1)

 LS mean (SE) changea

−0.5 (1.0)

3.3 (1.0)

 Difference (95 % CI) vs placebo

–

3.7 (1.0, 6.5)

 p value

–

0.007

Proinsulin/C-peptide

 N

69

74

 Mean (SD) baseline

0.0267 (0.0323)

0.0235 (0.0380)

 LS mean (SE) changea

0.0003 (0.0016)

−0.0024 (0.0015)

 Difference (95 % CI) vs placebo

–

−0.0026 (−0.0070, 0.0017)

 p value

–

0.235

HOMA2- %B (%)

 N

69

74

 Mean (SD) baseline

24.26 (13.92)

22.23 (11.12)

 LS mean (SE) changea

0.88 (1.42)

10.15 (1.37)

 Difference (95 % CI) vs placebo

–

9.27 (5.35, 13.19)

 p value

–

<0.001

  1. N number of patients, FPG fasting plasma glucose, SBP systolic blood pressure, DBP diastolic blood pressure, HDL-cholesterol high-density lipoprotein cholesterol, HOMA2- %B homeostasis model assessment 2 steady state beta cell function, LS mean least squares mean, 95 % CI, 95 % confidence interval
  2. aLS mean for change from the baseline to week 16, (factor treatment, covariate each parameter at baseline)