A randomized, placebo-controlled study of the cardiovascular safety of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus

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	Difference^a
With one or more AEs of hypoglycemia	513 (24.5)	454 (21.6)	2.9 (0.4, 5.5)
Symptomatic^b	472 (22.6)	414 (19.7)	2.8^f (0.4, 5.3)
Documented symptomatic^c	447 (21.4)	387 (18.4)	2.9 (0.5, 5.4)
Severe^d	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)
Asymptomatic^e	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

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