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Table 3 Adverse events (AEs) summary and AEs of hypoglycemia

From: A randomized, placebo-controlled clinical trial evaluating the safety and efficacy of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus inadequately controlled by glimepiride and metformin

Patients, n (%) Omarigliptin N = 153 Placebo N = 153 Differencea
With one or more
 AEs 88 (57.5) 43 (47.7) 9.8 (−1.4, 20.8)
 Drug-relatedb AEs 12 (7.8) 10 (6.5) 1.3 (−4.8, 7.5)
 Serious AEs 3 (2.0) 5 (3.3) −1.3 (−5.7, 2.8)
 Serious drug-relatedb AEs 2 (1.3) 0 (0.0) 1.3
 Who died 0 (0.0) 0 (0.0) 0.0
Who discontinued due to
 An AE 4 (2.6) 4 (2.6) 0.0 (−4.3, 4.3)
 A drug-relatedb AE 2 (1.3) 1 (0.7) 0.7
 A serious AE 0 (0.0) 1 (0.7) −0.7
 A serious drug-relatedb AE 0 (0.0) 0 (0.0) 0.0
With one or more AE of hypoglycemia 18 (11.8) 13 (8.5) 3.3 (−3.6, 10.3)
 Symptomaticc 16 (10.5) 13 (8.5) 2.0f (−4.8, 8.8)
 Severed 5 (3.3) 1 (0.7) 2.6 (−0.7, 6.9)
 Asymptomatice 2 (1.3) 0 (0.0) 1.3
  1. aDifference in % vs placebo; estimate (95% CI) was computed only for AE summary with incidence of at least 4 patients in any treatment group, any adverse event of hypoglycemia and adverse events of severe hypoglycemia
  2. bAssessed by the investigator as related to study drug
  3. cSymptomatic hypoglycemia: episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level
  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: fingerstick glucose values ≤3.9 mmol/L (70 mg/dL) without symptoms
  6. fp = 0.559