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 4

Incidence rate of AEs and their specifications and characteristics.

	Metformin Arm 1 (N = 76)	Low-dose NW Low-Glu® Arm 2 (N = 78)	High-dose NW Low-Glu® Arm 3 (N = 78)	Total (N = 232)
Frequency of AEs, no. of events (%)	1 (1.3)	4 (5.1)	5 (6.4)	10 (4.3)
AE specification
Diarrhea	0	1 (1.3)	0	1 (0.4)
Upper abdominal pain	1 (1.3)	2 (2.6)	0	3 (1.3)
Hyperglycemia	0	1 (1.3)	2 (2.6)	3 (1.3)
Ketoacidosis	0	0	1 (1.3)	1 (0.4)
Headache	0	0	1 (1.3)	1 (0.4)
Somnolence	0	0	1 (1.3)	1 (0.4)
Characteristics of AEs
Intensity
Mild	0	3 (3.8%)	0	3 (30)
Moderate	0	1 (1.3%)	5 (6.4%)	6 (60)
Severe	1 (1.3%)	0	0	1 (10)
Relatedness to study medication
Related	0	0	0	0
Probably/Likely related	1 (1.3%)	0	0	1 (10)
Possibly related	0	0	5 (6.4%)	5 (50)
Unlikely related or probably not related	0	1 (1.3%)	0	1 (10)
Unrelated	0	3 (3.8%)	0	3 (30)
Seriousness criteria
Serious	0	0	0	0
Not serious	1 (100%)	4 (100%)	5 (100%)	10 (100)