Research Article

A Phase II, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of NW Low-Glu® in Patients Newly Diagnosed with Type 2 Diabetes Mellitus

Table 1

Demographics and baseline characteristics of the study population (N = 198).

Metformin Arm 1 (N = 64)Low-dose NW Low-Glu® Arm 2 (N = 65)High-dose NW Low-Glu® Arm 3 (N = 69)

Characteristic
Age (yrs), median (IQR)49 (16)50 (14)39 (13.5)
BMI (kg/m2), mean±SD33.1 ± 3.831.5 ± 3.931.6 ± 4.2
SBP (mmHg), mean±SD124.6 ± 10.4124.2 ± 13.4123.1 ± 12.02
DBP (mmHg), mean±SD78.9 ± 6.277.9 ± 7.977.4 ± 6.9
Diabetes duration (months), mean±SD7.1 ± 9.96.3 ± 9.56.8 ± 10.1
Smoking duration (yrs), mean±SD18.5 ± 8.721.8 ± 12.125.2 ± 9.6
Gender, no. (%)
Females41 (64.1)33 (50.8)37 (53.8)
Males23 (35.9)32 (49.2)32 (46.4)

Marital status, no. (%)
Single02 (3.1)0
Married59 (92.2)60 (92.3)66 (95.7)
Widow3 (4.7)2 (3.1)2 (2.9)
Divorced2 (3.1)1 (1.5)1 (1.4)

Education, no. (%)
None7 (10.9)4 (6.2)1 (1.4)
Basic/primary11 (17.2)8 (12.3)14 (20.3)
Secondary37 (57.8)35 (53.8)41 (59.4)
Graduate or higher9 (14.1)18 (27.7)13 (18.8)

Employment, no. (%)
Unemployed25 (39.1)21 (32.3)23 (33.3)
Employed33 (51.6)39 (60.0)44 (63.8)
Retired6 (9.4)5 (7.7)2 (2.9)

Residence, no. (%)
Urban56 (87.5)59 (90.8)62 (89.9)
Rural8 (12.5)6 (9.2)7 (10.1)

Physical examination, no. (%)
Normal64 (100)65 (100)69 (100)
Abnormal000

Family history of diabetes
no. (%)41 (64.1)40 (61.5)45 (65.2)

Smoking habits, no. (%)
Never53 (82.8)52 (80.0)58 (84.1)
Former3 (4.7)3 (4.6)0
Current8 (12.5)10 (15.4)11 (15.9)