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 2

Efficacy variables among treatment arms.

	Metformin Arm 1 (N=64)		Low-dose NW Low-Glu® Arm 2 (N = 65)		High-doseLow-Glu®Arm 3 (N = 69)
	Baseline	Week 12	Baseline	Week 12	Baseline	Week 12
HbA1c (%)
Count	64	51	65	54	69	52
Mean (SD)	8.7 (1.9)	7.7 (1.6)	8.5 (1.4)	7.8 (1.6)	8.8 (1.9)	8.1 (1.8)
Mean change (SD)	−0.9 (1.9)		−0.6 (1.4)		−0.8 (1.7)
-value (Wilcoxon signed rank test)	0.002		0.004		0.002
Mann–Whitney test comparing Active Control and Arm 2 revealed ; Mann–Whitney comparing Active Control and Arm 3 revealed ; Kruskal–Wallis One-Way ANOVA test comparing the three arms revealed;
Fasting plasma glucose (FPG) (mg/dL)
Count	64	62	65	60	69	63
Mean (SD)	162.9 (62.6)	154.5 (68.5)	158.4 (72.7)	144.8 (53.6)	169.5 (71.7)	159.2 (50.4)
Mean change (SD)	−9.5 (59.1)		−13.4 (66.0)		−10.5 (65.2)
P value (Wilcoxon signed rank test)	0.2		0.1		0.2
Mann–Whitney test comparing Active Control and Arm 2 revealed ; Mann–Whitney test comparing Active Control and Arm 3 revealed ; Kruskal–Wallis One-Way ANOVA test comparing the three arms revealed
2hr post prandial glucose (2hr PPG) (mg/dL)
Count	60	60	63	58	67	62
Mean (SD)	237.8 (88.7)	200.6 (88.5)	243.7 (104.3)	198.5 (77.5)	246.2 (88.8)	221.7 (84.8)
Mean change (SD)	−38.2 (101.6)		−35.4 (74.9)		−24.7 (100.8)
P value (Wilcoxon signed rank test)	0.01		0.001		0.04
Mann–Whitney test comparing Active Control and Arm 2 revealed ; Mann–Whitney comparing Active Control and Arm 3 revealed ; Kruskal–Wallis One-Way ANOVA test comparing the three arms revealed
HOMA-IR
Count	58	52	59	55	67	52
Mean (SD)	2.4 (1.5)	2.6 (1.7)	2.3 (1.3)	2.1 (1.3)	2.7 (1.8)	2.7 (1.8)
Mean change (SD)	−0.001 (1.3)		−0.3 (1.3)		−0.01± 1.4
-value (Wilcoxon signed rank test)	0.9		0.1		0.6
Mann–Whitney test comparing active Control and Arm 2 revealed ; Mann–Whitney test comparing active Control and Arm 3 revealed ; Kruskal–Wallis One-Way ANOVA test comparing the three arms revealed
HOMA-β
Count	58	51	58	53	67	52
Mean (SD)	74.3 (49.1)	82.8 (60.6)	77.7 (52.6)	79.7 (49.7)	73.4 (60.7)	77.8 (64.8)
Mean change (SD)	−4.4 ± 68.6		1.2 ±49.1		2.79 ± 78.7
value (Wilcoxon signed rank test)	0.9		0.4		0.4
Mann–Whitney test comparing Active Control and Arm 2 revealed ; Mann–Whitney test comparing Active Control and Arm 3 revealed ; Kruskal–Wallis One-Way ANOVA comparing the three arms revealed;
Weight (Kg)
Mean (SD)	91.2 (10.6)	90.4 (10.9)	88.4 (12.5)	87.5 (12.8)	85.6 (12.5)	84.5 (12.2)
Mean change (SD)	−0.8 ±1.8		−0.9 ± 1.5		−1.1 ± 1.7
value (Wilcoxon signed rank test)	0.001		0.001		0.001
Mann–Whitney test comparing Active Control and Arm 2 revealed ; Mann–Whitney comparing Active Control and Arm 3 revealed ; Kruskal–Wallis One-Way ANOVA comparing the three arms revealed
Plasma alpha-glucosidase activity (nmol/mL/hour)
Count	60	62	63	60	67	65
Mean (SD)	1.6 (1.3)	1.6 (1.3)	1.5 (1.1)	1.6 (1.3)	1.7 (1.5)	1.4 (1.3)
Mean change (SD)	−0.04 ± 1.9		0.12 ± 1.7		−0.4 ± 1.4
value (Wilcoxon signed rank test)	0.23		0.5		0.04
Mann–Whitney test comparing Active Control and Arm 2 revealed ; Mann–Whitney test comparing Active Control and Arm 3 revealed ; Kruskal–Wallis One-Way ANOVA test comparing the three arms revealed;