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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