Randomized, Double-Blinded, Double-Dummy, Active-Controlled, and Multiple-Dose Clinical Study Comparing the Efficacy and Safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Acarbose in Individuals with Type 2 Diabetes Mellitus
Table 1
Baseline characteristics of trial population.
SZ-A ()
Acarbose ()
value
Demographics
Age (years)
56 (9.71)
57 (6.70)
0.747
Gender (male/female)
8/15
5/10
1.000
Comorbidities
Hypertension
6 (26.1%)
6 (40.0%)
0.481
Hyperlipidaemia
17 (73.9%)
10 (66.7%)
0.722
Concomitant drug use
Metformin
12 (52%)
7 (47%)
1.000
Antilipidemic
2 (0.09%)
0
NA
Antihypertensive
1 (0.04%)
0
NA
Metabolic factors
Disease duration (months)
36 (6,180)
30 (9,120)
0.800
Fasting glucose (mmol/L)
8.94 (1.63)
8.85 (1.56)
0.873
HbA1c (%)
8.30 (0.91)
8.24 (0.95)
0.847
Weight (kg)
71.63 (12.06)
69.30 (13.00)
0.576
BMI (kg/m2)
25.67 (2.744)
25.47 (2.612)
0.822
Systolic blood pressure (mmHg)
131.48 (11.735)
129.67 (15.267)
0.682
Diastolic blood pressure (mmHg)
81.39 (8.217)
78.67 (9.123)
0.345
Smoking history (current smoker)
1 (4.3%)
4 (26.7%)
0.069
Drinking history (current drinker)
2 (8.7%)
0
NA
Proteinuria
0.898
0
12 (63.2%)
9 (64.3%)
—
Trace
5 (26.3%)
4 (28.6%)
—
1+
2 (10.5%)
1 (7.1%)
—
Glycosuria
0
12 (63.2%)
7 (50.0%)
1.000
Trace
2 (10.5%)
3 (21.4%)
0.365
1+
0
1 (7.1%)
NA
2+
0
0
NA
3+
2 (10.5%)
3 (21.4%)
0.365
4+
3 (15.8%)
0
NA
Lipids
Total cholesterol (mmol/L)
5.17 (1.06)
4.85 (0.91)
0.350
Triglycerides (mmol/L)
2.26 (1.30)
1.89 (1.12)
0.367
HDL (mmol/L)
1.18 (0.37)
1.15 (0.27)
0.803
LDL (mmol/L)
3.04 (0.93)
2.97 (0.69)
0.790
Liver function tests
Alanine aminotransferase (U/L)
22.39 (9.41)
26.60 (15.04)
0.294
Aspartate aminotransferase (U/L)
17.91 (5.43)
20.07 (6.27)
0.269
Kidney function tests
Creatinine clearance (mL/min)
77.08 (20.66)
76.59 (14.56)
0.937
Uric acid (mmol/L)
292.91 (80.62)
241.20 (90.95)
0.078
ECG
Normal
11 (57.89%)
7 (50%)
1.000
ST segment depression
2 (10.53%)
0 (0%)
NA
T wave nonspecific changes
3 (15.79%)
3 (21.43%)
0.663
Low voltage
1 (5.26%)
0 (0%)
NA
High voltage of left ventricle
1 (5.26%)
1 (7.14%)
1.000
PR interval shortened
1 (5.26%)
0 (0%)
NA
Left ventricle hypertrophy
0 (0%)
1 (7.14%)
NA
Right atrium hypertrophy
0 (0%)
1 (7.14%)
NA
Sinus bradycardia
0 (0%)
1 (7.14%)
NA
Compliance (%)
97.66 (2.95)
97.36 (2.08)
0.734
Data are mean (SD) or (%) or median (minimum, maximum). Independent-samples -test. Chi-square tests (Fisher’s exact test). Nonparametric tests. Chi-square tests (Monte Carlo exact test).
