Apidra (insulin glulisine) - Sanofi Canada
Apidra (insulin glulisine) - Sanofi Canada
Apidra (insulin glulisine) - Sanofi Canada
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Clinical Trial Adverse Drug Reactions<br />
Because clinical trials are conducted under very specific conditions the adverse reaction rates<br />
observed in the clinical trials may not reflect the rates observed in practice and should not be<br />
compared to the rates in the clinical trials of another drug. Adverse drug reaction information<br />
from clinical trials is useful for identifying drug-related adverse events and for approximating<br />
rates.<br />
Table 3 - Common (≥1%) Adverse Drug Reactions in pooled adult Type 1 and 2 studies<br />
Adverse Event<br />
System Organ Class/<br />
Preferred Term<br />
General Disorders and<br />
Administration Site<br />
Condition<br />
Injection site hypertrophy<br />
Metabolism and Nutrition<br />
Disorders<br />
Hypoglycemia NOS*<br />
Hypoglycemic seizure<br />
Hypoglycemic<br />
unawareness<br />
Nervous System<br />
Disorders<br />
Hypoglycemic coma<br />
*Not otherwise specified<br />
Insulin Glulisine<br />
(All studies)<br />
n=1833<br />
(% of subjects)<br />
9 (0.5)<br />
83 (4.5)<br />
16 (0.9)<br />
1 (0.1)<br />
49 (2.7)<br />
Lispro<br />
n= 333<br />
(% of subjects)<br />
7 (2.1)<br />
22 (6.6)<br />
7 (2.1)<br />
4 (1.2)<br />
13 (3.9)<br />
Regular<br />
Insulin<br />
n=1161<br />
(% of<br />
subjects)<br />
- (-)<br />
33 (2.8)<br />
9 (0.8)<br />
- (-)<br />
19 (1.6)<br />
Aspart<br />
n= 30<br />
(% of<br />
subjects)<br />
- (-)<br />
2 (6.7)<br />
- (-)<br />
2 (6.7)<br />
Table 4 summarizes the adverse reactions occurring with frequency higher than 1% in a clinical<br />
study in children and adolescents with type 1 diabetes treated with <strong>insulin</strong> <strong>glulisine</strong> (n=277) or<br />
<strong>insulin</strong> lispro.<br />
- (-)<br />
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