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Table 6 Analysis of adverse events (AEs) of hypoglycemia in the APaT population Treatment Period + 21 days

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

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)
  1. aDifference in % vs. placebo
  2. bSymptomatic hypoglycemia: episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level
  3. cDocumented symptomatic: episode with clinical symptoms attributed to hypoglycemia with a documented glucose levels of ≤3.9 mmol/L (≤70 mg/dL)
  4. 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
  5. eAsymptomatic hypoglycemia: finger stick glucose values ≤3.9 mmol/L (70 mg/dL) without symptoms
  6. fp = 0.024