|
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
|
-
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
-
bAssessed by the investigator as related to study drug
-
cSymptomatic hypoglycemia: episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level
-
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: fingerstick glucose values ≤3.9 mmol/L (70 mg/dL) without symptoms
-
fp = 0.559
