Table 4.

Treatment emergent (TE) serious adverse effects (SAEs), discontinuations and AEs of special interest

	Placebo	10 μg BID	30 μg BID	100 μg BID
Number of Patients	104	98	109	82
Completed (%)	92 (86%)	86 (88%)	93 (85%)	63 (77%)
TE SAEs	8 (7.7%)	7 (7.1%)	10 (9.2%)	6 (7.3%)
Reasons for Discontinuation
Discontinued (%)	15 (14%)	13 (13%)	17 (16%)	19 (23%)
TEAEs (%)	3 (2.9%)	3 (3.1%)	8 (7.3%)	9 (11.0%)
Withdrew Consent	4 (3.8%)	8 (8.2%)	7 (6.4%)	6 (7.3%)
Lost to Follow-Up	3 (2.9%)	2 (2.0%)	2 (1.8%)	3 (3.7%)
Other	4 (3.8%)			1 (1.2%)
TEAEs of Special Interest
Hyperglycemia AEs	3 (2.9%)	8 (8.2%)	17 (15.6%)	17 (20.7%)
DKA (serious AE)	0 (0.0%)	1 (1.0%)	1 (0.9%)	1 (1.2%)
LFT AEs	1 (1.0%)	2 (2.0%)	4 (3.7%)	2 (2.4%)
GI Disorders	13 (12.5%)	6 (6.1%)	18 (16.5%)	13 (15.9%)
Diarrhea	0 (0.0%)	4 (4.1%)	7 (7.3%)	6 (6.4%)