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Table 3 Summary of laboratory 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)

Sodium (mmol/l)

N

72

77

87

93

Baseline

138.9 (2.3)

138.5 (2.9)

138.6 (2.3)

139.1 (2.2)

Change at week 102

-0.04 [2.7]

0.2 [2.8]

0.1 [2.6]

0.1 [2.6]

P vs PBO + MET

 

0.1434

0.1905

0.3978

Potassium (mmol/l)

n

72

77

87

93

Baseline

4.35 (0.47)

4.34 (0.46)

4.37 (0.39)

4.37 (0.43)

Change at week 102

-0.08 [0.55]

-0.01 [0.45]

-0.05 [0.35]

-0.07 [0.47]

P vs PBO + MET

 

0.3366

0.4563

0.9918

Serum creatinine (μmol/l)

n

72

77

88

93

Baseline

76.9 (17.9)

78.7 (18.1)

79.6 (19.3)

77.8 (17.8)

Change at week 102

-0.9 [10.3]

-1.8 [9.7]

-3.5 [12.7]

-2.7 [10.6]

P vs PBO + MET

 

0.9954

0.4720

0.9032

Serum uric acid (μmol/l) a

n

28

35

47

57

Baseline

314 (79)

322 (80)

323 (88)

323 (80)

Change at week 102

-1.78 [54.13]

-55.9 [50.32]

-46.4 [64.36]

-52.9 [64.36]

P vs PBO + MET

 

0.0054

0.0013

0.0002

Blood urea nitrogen (mmol/l)

n

72

77

88

93

Baseline

5.33 (1.55)

5.51 (1.41)

5.65 (1.81)

5.34 (1.41)

Change at week 102

0.56 [1.24]

0.70 [1.54]

0.42 [1.87]

0.73 [1.44]

P vs PBO + MET

 

0.2299

0.4169

0.0845

Hematocrit (%)

n

71

78

87

93

Baseline

42.61 (3.90)

42.38 (3.99)

42.15 (3.59)

42.88 (3.95)

Change at week 102

-1.43 [3.29]

0.84 [2.53]

1.35 [2.48]

1.54 [2.78]

P vs PBO + MET

 

<0.0001

<0.0001

<0.0001

Hemoglobin (g/l)

n

71

78

87

94

Baseline

142.8 (13.45)

142.5 (14.25)

141.6 (12.19)

143.6 (13.10)

Change at week 102

-4.9 [10.14]

1.5 [7.73]

3.1 [8.40]

4.1 [8.84]

P vs PBO + MET

 

<0.0001

<0.0001

<0.0001

Systolic blood pressure (mmHg)

n

72

78

88

94

Baseline

128 (15)

127 (14)

127 (14)

126 (16)

Change at week 102

1.5 [13.7]

0.7 [16.1]

-1.1 [13.2]

-0.3 [15.0]

P vs PBO + MET

 

0.1111

0.0136

0.0067

Diastolic blood pressure (mmHg)

n

72

78

88

94

Baseline

81 (9)

80 (9)

81 (9)

79 (10)

Change at week 102

-1.0 [7.9]

-0.1 [8.1]

-1.5 [8.1]

-1.2 [10.1]

P vs PBO + MET

 

0.6605

0.2140

0.1075

  1. Data are means (SD) at baseline or mean changes [SE] from baseline at week 102 including data after rescue unless noted. n is the number of treated patients with non-missing baseline and week 102 values for the specific test. aExcluding data after rescue. DAPA = dapagliflozin; MET = metformin; PBO = placebo.