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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