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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  03/14/2008
 
Trade Name:  NovoLog
 
Generic or Proper Name (*):  insulin aspart [rDNA origin] injection
 
Indications Studied:  Insulin analog indicated to improve glycemic control
 
Therapeutic Category:  Antidiabetic
 
Ages Studied:  4-18 years
 
Study #:  2
 
Study Type:  Efficacy/Safety
 
Study Design:  Open Label/Active Control/Parallel Group
 
No Patients:  61
 
No Centers:  5
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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