Table 3.

Incidence and event rate of symptomatic, confirmed symptomatic with blood glucose <50 mg/dl and severe hypoglycaemia during 24 weeks

Baseline OAD number/class	Incidence, n/N (%)	p*	Event rate per subject-year, least squares mean (s.e.)	p*
Symptomatic hypoglycaemia
0/1 OAD	424/1020 (41.6)	0.0007	4.05 (0.71)	0.0009
2 OADs	713/1134 (62.9)		7.18 (0.43)
MET only	51/185 (27.6)	<0.0001	1.81 (1.06)	<0.0001
SU only	352/792 (44.4)		4.88 (0.90)
MET + SU	687/1084 (63.4)		7.30 (0.43)
Confirmed symptomatic hypoglycaemia with blood glucose <50 mg/dl†
0/1 OAD	175/1013 (17.3)	0.0122	0.99 (0.22)	0.0643
2 OADs	375/1080 (34.7)		1.53 (0.13)
MET only	16/178 (9.0)	0.0006	0.67 (0.34)	0.0576
SU only	149/792 (18.8)		1.05 (0.27)
MET + SU	365/1030 (35.4)		1.56 (0.14)
Severe symptomatic hypoglycaemia†
0/1 OAD	12/1013 (1.2)	0.6444	0.01 (0.05)	0.4416
2 OADs	14/1080 (1.3)		0.06 (0.03)
MET only	2/178 (1.1)	0.6329	0.00 (0.07)	0.7231
SU only	10/792 (1.3)		0.02 (0.06)
MET + SU	14/1030 (1.4)		0.06 (0.03)

Event rate per subject-year = 365.25 × number of events/exposure (days). MET, metformin; OAD, oral antidiabetic drug; s.e., standard error; SU, sulfonylurea.

^*p Values for categorical variables were from Cochran–Mantel–Haenszel statistics, which test general association between hypoglycaemia events and baseline OAD status. p Values for continuous variables were from analysis of variance models, including study and baseline OAD status as factors.

^†Study 6001 was excluded because no detailed information of hypoglycaemia was collected.