Paediatric Subjects - Special Survey

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01538576
First received: February 15, 2012
Last updated: March 3, 2016
Last verified: March 2016

February 15, 2012
March 3, 2016
December 2003
October 2009   (final data collection date for primary outcome measure)
  • Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01538576 on ClinicalTrials.gov Archive Site
  • Hypoglycaemic events [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Paediatric Subjects - Special Survey
Special Survey for Paediatric Subjects
This study is conducted in Japan. The aim of this study is to collect safety and efficacy data when using insulin aspart in children with diabetes under normal clinical practice conditions.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients under 15 years of age with diabetes requiring insulin therapy with no treatment history of insulin aspart (NovoRapid®)
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Drug: insulin aspart
Prescribed by the physicians as a result of normal clinical practice
Insulin aspart users
Intervention: Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with diabetes requiring insulin therapy

Exclusion Criteria:

  • Subjects who had treatment history of insulin aspart
Both
up to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01538576
BIASP-1942
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP