Table 6.

Analysis of adverse events (AEs) of hypoglycemia in the APaT population Treatment Period + 21 days

Patients, n (%)	Omarigliptin N = 2092	Placebo N = 2100	Differencea
With one or more AEs of hypoglycemia	513 (24.5)	454 (21.6)	2.9 (0.4, 5.5)
Symptomaticb	472 (22.6)	414 (19.7)	2.8f (0.4, 5.3)
Documented symptomaticc	447 (21.4)	387 (18.4)	2.9 (0.5, 5.4)
Severed	88 (4.2)	70 (3.3)	0.9 (−0.3, 2.0)
Requiring non-medical assistance	82 (3.9)	58 (2.8)	1.2 (0.1, 2.3)
Requiring medical assistance	11 (0.5)	19 (0.9)	−0.4 (−0.9, 0.1)
Asymptomatice	126 (6.0)	123 (5.9)	0.2 (−1.3, 1.6)

^aDifference in % vs. placebo

^bSymptomatic hypoglycemia: episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level

^cDocumented symptomatic: episode with clinical symptoms attributed to hypoglycemia with a documented glucose levels of ≤3.9 mmol/L (≤70 mg/dL)

^dSevere hypoglycemia: episode that required assistance, either medical or non-medical. Episodes with a markedly depressed level of consciousness, a loss of consciousness, or seizure were classified as having required medical assistance, whether or not medical assistance was obtained

^eAsymptomatic hypoglycemia: finger stick glucose values ≤3.9 mmol/L (70 mg/dL) without symptoms

^fp = 0.024