Table 3.

Hypoglycemia

	Baseline (n = 19)	Glimepiride + placebo (n = 18)	Glimepiride + linagliptin (n = 17)
Hypoglycemia during CGM
Total episodes	8	32	15
Level 1 episodes	6	30	14
Level 2 episodes	2	2	1
Patients without episode	17	6	12
Percent time spend in hypoglycemia during CGM
Total	0.0 (0.0–0.0)	0.3 (0–3.4)	0.1 (0–3.4)
Level 1	0.0 (0.0–0.0)	0.3 (0.0–3.0)	0.1 (0.0–0.7)
Level 2	0.0 (0.0–0.0)	0.0 (0.0–0.0)	0.0 (0.0–0.0)
Patient-reported hypoglycemia in maintenance phase (weeks 5–15 and 24–35)
Total episodes	N/A	10	16
Level 1 episodes		10	15
Level 2 episodes		0	1
Patients without episode		11	10
Hypoglycemia during meal and bicycle test
Level 1 episodes	1	2	2
Level 2 episodes	0	0	0

Data are n (counts) or median (interquartile range). A hypoglycemic episode verified by CGM is defined as glucose measurements ≤3.9 mmol/L in at least 20 consecutive minutes. Patient-reported episodes of hypoglycemia are defined as blood glucose <4.0 mmol/L confirmed by self-measured blood glucose measurements on a glucometer. Level 1 hypoglycemia is a glucose value of 3.0–3.9 mmol/L and level 2 hypoglycemia is defined as a glucose value <3.0 mmol/L. Both level 1 and level 2 hypoglycemia are per definition nonsevere hypoglycemia (no need of third-party assistance for recovery of hypoglycemia).