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Table 2 Outcome variables and effect of treatment

From: Metformin may adversely affect orthostatic blood pressure recovery in patients with type 2 diabetes: substudy from the placebo-controlled Copenhagen Insulin and Metformin Therapy (CIMT) trial

 

Outcomes at randomization

Outcomes at end of trial

Metformin + insulin

Placebo + insulin

Metformin + insulin

Placebo + insulin

Metformin vs placebo

Model 1

Metformin vs placebo

Model 2

Metformin vs placebo

Model 3

Resting systolic blood pressure (mmHg)

136.5 (16.2)

134.5 (14.2)

136.7 (16.2)

134.5 (13.9)

1.06 (− 1.48; 3.59); P = 0.42

1.06 (− 1.59; 3.72); P = 0.43

0.87 (− 1.80; 3.56); P = 0.52

Resting diastolic blood pressure (mmHg)

80.8 (10.0)

79.9 (8.7)

78.7 (9.3)

78.7 (7.9)

− 0.37 (− 1.86; 1.11); P = 0.62

− 0.01 (− 1.52; 1.54); P = 0.99

0.04 (− 1.50; 1.58); P = 0.96

Systolic blood pressure 30 s after standing (mmHg)

130.4 (18.5)

128.8 (15.8)

128.7 (18.6)

130 (18.2)

3.09 (0.47; 5.71); P = 0.02

3.33 (0.58; 6.08); P = 0.02

3.35 (0.57; 6.12); P = 0.02

Diastolic blood pressure 30 s after standing (mmHg)

80.5 (10.7)

80.8 (9.1)

78.1 (10)

79.8 (9.7)

1.17 (− 0.05; 2.39); P = 0.06

1.38 (− 0.12; 2.64); P = 0.03

1.30 (0.30; 2.57); P = 0.045

Systolic blood pressure 90 s after standing (mmHg)

135.4 (17.9)

134.6 (15.3)

136.8 (17.8)

135.2 (17.3)

− 0.01 (− 2.28; 2.26); P = 0.99

0.44 (− 1.92; 2.80); P = 0.71

0.61 (− 1.77; 2.99); P = 0.62

Diastolic blood pressure 90 s after standing (mmHg)

83 (10.9)

83.3 (9.1)

81.3 (10.4)

82.1 (9.5)

0.44 (− 0.73; 1.60); P = 0.46

0.64 (− 0.58; 1.86); P = 0.30

0.62 (− 0.62; 1.86); P = 0.33

Systolic blood pressure 180 s after standing (mmHg)

135.8 (18.4)

135.4 (16.6)

135.8 (17.5)

135.2 (16.9)

1.10 (− 0.89; 3.10); P = 0.28

0.99 (− 1.07; 3.05); P = 0.34

0.97 (− 1.11; 3.05); P = 0.36

Diastolic blood pressure 180 s after standing (mmHg)

83.0 (10.9)

83.3 (9.1)

81.3 (10.4)

82.1 (9.5)

0.48 (− 0.64; 1.59); P = 0.40

0.45 (− 0.72; 1.62); P = 0.45

0.36 (− 0.82; 1.54); P = 0.55

Orthostatic hypotension diagnosis N (%)

41 (21.8)

30.0 (16.4)

49 (25.8)

38 (20.8)

1.24 (0.66; 2.31) P = 0.51

1.33 (0.70; 2.54); P = 0.38

1.33 (0.70; 2.54); P = 0.38

Beat-to-beat

9 (6; 16)

9 (6; 15)

8 (6; 14)

9 (6; 15)

− 1.14 (− 2.37; 0.09); P = 0.07

− 1.19 (− 2.47; 0.09); P = 0.07

− 1.09 (− 2.38; 0.20); P = 0.10

Resting heart rate (beats pr. minute)

70.1 (10.4)

69.3 (10.3)

70.6 (11.0)

69.0 (10.5)

1.03 (− 0.51; 2.57); P = 0.19

1.19 (− 0.40; 2.79); P = 0.14

1.17 (− 0.44; 2.78); P = 0.16

Heart rate 30 s after standing (beats pr. minute)

80.2 (12.3)

79.2 (11.1)

80.3 (12.8)

79.0 (11.7)

0.09 (− 1.18; 1.36); P = 0.89

0.18 (− 1.15; 1.51); P = 0.79

0.8 (− 1.26; 1.41); P = 0.91

Heart rate 90 s after standing (beats pr. minute)

78.2 (11.9)

79.2 (12.4)

78.8 (12.6)

77.6 (11.5)

0.19 (− 0.92; 1.30); P = 0.74

0.04 (− 1.12; 1.20); P = 0.94

0.04 (− 1.21; 1.39); P = 0.95

Heart rate 180 s after standing (beats pr. minute)

79.2 (12.6)

78.4 (11.75)

78.6 (13.0)

77.8 (11.2)

0.40 (− 0.66; 1.46); P = 0.46

0.19 (− 0.90 1.28); P = 0.73

0.02 (− 1.07 1.11); P = 0.97

Vibration detection threshold (volts)

20 (15; 29)

22 (16; 32)

22.5 (16; 30)

20 (16; 30)

− 0.33 (− 1.99; 1.32); P = 0.70

− 0.40 (− 2.11; 1.32); P = 0.65

− 0.49 (− 2.12; 1.25); P = 0.58

DPN Vibration detection threshold (age-adjusted) N (%)

25 (13.7)

23 (12.2)

34 (18.0)

26 (14.3)

1.42 (0.64; 13.17) P = 0.39.

1.33 (0.57; 3.08); P = 0.51

1.33 (0.57; 3.08); P = 0.51

  1. Data are means (SD), medians (IQR) or numbers (%). Results of test for treatment effect are for continuous; outcomes linear regression estimates in absolute values (95% CL) and P values for group difference and for binary outcome; metformin associated odds ratios (95% CL) and P values for group difference. Models 1 adjusted for baseline values the outcome variable. Model 2 additionally adjusted for metformin treatment prior to trial and change in serum vitamin B12 and methyl malonic acid during trial. Model 3 additionally adjusted for change in HbA1c during trial