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Table 1 Change from baseline in efficacy parameters

From: Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial

 

Placebo + metformin (n = 137)

Dapagliflozin 2.5 mg + metformin (n = 137)

Dapagliflozin 5 mg + metformin (n = 137)

Dapagliflozin 10 mg + metformin (n = 135)

HbA1c (%):a

    

Baseline (SD)

8.12 (0.96)

7.99 (0.90)

8.17 (0.96)

7.92 (0.82)

Change at week 24 (95% CI)

-0.31 (-0.45 to -0.16)

-0.65 (-0.79 to -0.51)

-0.67 (-0.81 to -0.53)

-0.82 (-0.96 to -0.68)

Difference vs PBO (95% CI)

 

-0.35 (-0.55 to -0.14)

-0.36 (-0.56, -0.16)

-0.51 (-0.71, -0.31)

Change at week 102 (95% CI)

0.02 (-0.20 to 0.23)

-0.48 (-0.68 to -0.29)

-0.58 (-0.77 to -0.39)

-0.78 (-0.97 to -0.60)

Difference vs PBO (95% CI)

 

-0.50 (-079 to -0.21)

-0.60 (-0.89 to -0.31)

-0.80 (-1.08 to -0.52)

Pvs PBO + MET

 

0.0008

<0.0001

<0.0001

FPG (mmol/l): a

    

Baseline (SD)

9.19 (2.58)

8.96 (2.39)

9.39 (2.72)

8.66 (2.15)

Change at week 24 (95% CI)

-0.29 (-0.59 to 0.01)

-0.95 (-1.23 to -0.67)

-1.15 (-1.44 to -0.88)

-1.23 (-1.51 to -0.94)

Difference vs PBO (95% CI)

 

-0.66 (-1.07 to -0.25)

-0.87 (-1.28 to -0.46)

-0.94 (-1.35 to -0.53)

Change at week 102 (95% CI)

-0.58 (-0.97 to -0.19)

-1.07 (-1.42 to -0.72)

-1.47 (-1.78 to -1.16)

-1.36 (-1.65, -1.07)

Difference vs PBO (95% CI)

 

-0.49 (-0.99 to 0.01)

-0.89 (-1.37 to -0.41)

-0.78 (-1.25 to -0.31)

Pvs PBO + MET

 

0.0518

0.0003

0.0012

Weight (kg): a

    

Baseline (SD)

87.74 (19.24)

84.90 (17.77)

84.73 (16.26)

86.28 (17.53)

Change at week 24 (95% CI)

-0.40 (-0.91 to 0.11)

-1.96 (-2.47 to -1.44)

-2.92 (-3.43 to -2.41)

-2.65 (-3.16 to -2.13)

Difference vs PBO (95% CI)

 

-1.55 (-2.27 to -0.84)

-2.52 (-3.23 to -1.80)

-2.24 (-2.96 to -1.53)

Change at week 102 (95% CI)

1.36 (0.53 to 2.20)

-1.10 (-1.91 to -0.29)

-1.70 (-2.48 to -0.91)

-1.74 (-2.51 to -0.96)

Difference vs PBO (95% CI)

 

-2.46 (-3.63 to -1.30)

-3.06 (-4.21 to -1.92)

-3.10 (-4.24 to -1.96)

Pvs PBO + MET

 

<0.0001

<0.0001

<0.0001

Percentage of patients with HbA1c <7.0% (95% CI): b

    

At week 24

24.2 (17.4 to 30.9)

30.9 (23.4 to 38.4)

35.9 (28.4 to 43.5)

38.2 (30.3 to 46.1)

Difference vs PBO (95% CI)

 

6.7 (-3.2 to 16.6)

11.8 (1.9 to 21.6)

14.0 (3.9 to 24.1)

At week 102

15.4 (9.5 to 21.3)

20.7 (14.0 to 27.3)

26.4 (19.4 to 33.4)

31.5 (23.7 to 39.3)

Difference vs PBO (95% CI)

 

5.3 (-3.5 to 14.1)

11.0 (1.9 to 20.0)

16.1 (6.4 to 25.7)

Pvs PBO + MET

 

0.2380

0.0176

0.0011

  1. n indicates the number of randomized patients who took at least one dose of double-blind study medication. Data are means (SD) or means (95% CI). aAdjusted mean change from baseline using longitudinal repeated measures, excluding data after rescue, except weight, which includes data after rescue. bPercentage adjusted for baseline glycated hemoglobin (HbA1c). Patients discontinued or rescued prior to week t (t = 24 or 102) or missed measurements at week t are considered not achieving glycemic response. DAPA = dapagliflozin; FPG = fasting plasma glucose; MET = metformin; PBO = placebo.
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BMC Medicine

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