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Table 3 Change in the levels of major efficacy parameters from baseline

From: Efficacy and safety of enavogliflozin vs. dapagliflozin as add-on therapy in patients with type 2 diabetes mellitus based on renal function: a pooled analysis of two randomized controlled trials

 

Normal eGFR

(eGFR ≥ 90 mL/min/1.73m2)

Mildly reduced eGFR

(60 ≤ eGFR < 90 mL/min/1.73m2)

Enavogliflozin 0.3 mg (n = 91)

Dapagliflozin 10 mg (n = 105)

Enavogliflozin 0.3 mg (n = 123)

Dapagliflozin 10 mg (n = 108)

HbA1c, %

    

 Baseline

7.81 (0.83)

7.78 (0.82)

7.74 (0.77)

7.75 (0.75)

 Week 24

7.00 (0.59)

6.88 (0.67)

6.85 (0.55)

7.02 (0.67)

 Change from baseline at week 24

    

  LS mean (SE)

-0.88 (0.06)

-0.97 (0.06)

-0.94 (0.05)

-0.77 (0.06)

  LS mean difference [95% Cl], p-value

0.09 [-0.05, 0.24], p = 0.2063

-0.17 [-0.31, -0.03], p = 0.0196

HbA1c, mmol/mol

    

 Baseline

61.90 (9.06)

61.55 (8.91)

61.12 (8.39)

61.20 (8.18)

 Week 24

53.02 (6.41)

51.75 (7.34)

51.33 (6.01)

53.17 (7.36)

 Change from baseline at week 24

    

  LS mean (SE)

-9.62 (0.69)

-10.65 (0.62)

-10.26 (0.60)

-8.42 (0.63)

  LS mean difference [95% Cl], p-value

1.03 [-0.57, 2.63], p = 0.2063

-1.84 [-3.39, -0.30], p = 0.0196

FPG, mg/dL

    

 Baseline

146.53 (29.00)

146.62 (30.70)

138.67 (25.87)

141.94 (31.02)

 Week 24

114.75 (18.28)

116.39 (18.93)

112.19 (16.71)

118.15 (21.93)

 Change from baseline at week 24

    

  LS mean (SE)

-32.01 (1.97)

-30.18 (1.78)

-28.54 (1.78)

-23.52 (1.93)

  LS mean difference [95% Cl], p-value

-1.83 [-6.48, 2.82], p = 0.4382

-5.03 [-9.75, -0.30], p = 0.0371

Body weight, kg

    

 Baseline

68.93 (11.94)

70.24 (12.58)

70.23 (11.42)

67.03 (10.51)

 Week 24

65.69 (11.50)

67.00 (12.62)

66.72 (11.10)

63.95 (10.00)

 Change from baseline at week 24

    

  LS mean (SE)

-3.25 (0.27)

-3.21 (0.24)

-3.57 (0.30)

-3.39 (0.32)

  LS mean difference [95% Cl], p-value

-0.04 [-0.67, 0.59], p = 0.9033

-0.18 [-0.96, 0.61], p = 0.6587

UGCR, g/g

    

 Baseline

1.65 (8.88)

2.65 (10.11)

0.66 (3.44)

0.70 (2.92)

 Week 24

67.75 (22.21)

47.18 (25.01)

54.78 (21.92)

41.79 (17.37)

 Change from baseline at week 24

    

  LS mean (SE)

64.23 (2.75)†

43.79 (2.48)‡

55.06 (1.96)

41.95 (2.11)

  LS mean difference [95% Cl], p-value

20.44 [13.92, 26.97], p < 0.0001

13.11 [7.91, 18.31], p < 0.0001

HOMA-β

    

 Baseline

39.04 (25.37)

43.72 (28.16)

47.79 (34.97)

40.61 (24.55)

 Week 24

50.53 (41.70)

54.47 (39.95)

47.03 (65.99)

49.40 (29.01)

 Change from baseline at week 24

    

  LS mean (SE)

14.98 (3.95)

13.96 (3.54)

1.15 (4.62)

9.52 (4.97)

  LS mean difference [95% Cl], p-value

1.01 [-8.33, 10.36], p = 0.8311

-8.37 [-20.67, 3.93], p = 0.1812

HOMA-IR

    

 Baseline

3.09 (2.18)

3.57 (2.42)

3.19 (3.03)

3.00 (1.92)

 Week 24

1.85 (1.21)

2.08 (1.42)

1.77 (1.00)

2.21 (1.72)

 Change from baseline at week 24

    

  LS mean (SE)

-1.35 (0.12)

-1.30 (0.11)

-1.34 (0.13)

-0.84 (0.14)

  LS mean difference [95% Cl], p-value

-0.05 [-0.33, 0.24], p = 0.7498

-0.50 [-0.84, -0.16], p = 0.0038

SBP, mmHg§

    

 Baseline

127.11 (10.93)

125.47 (12.07)

129.49 (14.54)

125.34 (13.66)

 Week 24

122.41 (11.64)

120.85 (11.07)

123.04 (13.25)

120.56 (12.74)

 Change from baseline at week 24

    

  LS mean (SE)

-3.49 (1.11)

-4.24 (1.00)

-6.55 (0.95)

-6.54 (1.02)

  LS mean difference [95% Cl], p-value

0.75 [-1.88, 3.38], p = 0.5746

-0.02 [-2.55, 2.52], p = 0.9901

DBP, mmHg§

    

 Baseline

76.95 (8.89)

75.84 (8.25)

76.68 (9.87)

73.65 (10.42)

 Week 24

73.47 (9.17)

73.00 (8.13)

71.99 (9.56)

71.39 (9.40)

 Change from baseline at week 24

    

  LS mean (SE)

-3.22 (0.81)

-2.98 (0.72)

-4.68 (0.68)

-3.47 (0.73)

  LS mean difference [95% Cl], p-value

-0.24 [-2.14, 1.66], p = 0.8019

-1.21 [-3.01, 0.60], p = 0.1887

  1. Data are primarily based on the per-protocol set and presented as mean (standard deviation) unless otherwise specified. †As one subject did not have week 24 value, total 90 patients’ data were used for calculation of change from baseline. ‡As one subject did not have baseline value, total 104 patients’ data were used for calculation of change from baseline. §Blood pressure data are based on the modified per-protocol set 2 (Enavogliflozin (n = 87), Dapagliflozin (n = 102) in Normal eGFR group and Enavogliflozin (n = 120), Dapagliflozin (n = 106) in Mildly reduced eGFR group)
  2. Testing for difference between Enavogliflozin and Dapagliflozin (ANCOVA with treatment group as a factor, baseline value and stratification factors as covariates)
  3. DBP: diastolic blood pressure; FPG: fasting plasma glucose; HbA1c: glycated hemoglobin; HOMA-β: homeostasis model assessment of β-cell function; HOMA-IR: homeostasis model assessment of insulin resistance; SBP: systolic blood pressure; UACR: urine albumin-to-creatinine ratio; UGCR; urine glucose-to-creatinine ratio
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Cardiovascular Diabetology

ISSN: 1475-2840