Special Survey for Patients With Type 1 or Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01538589
First received: February 15, 2012
Last updated: February 20, 2012
Last verified: February 2012

February 15, 2012
February 20, 2012
December 2003
October 2009   (final data collection date for primary outcome measure)
  • Occurrence of severe hypoglycaemic symptoms [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Occurrence of severe hypoglycaemic symptoms [ Time Frame: Year 2 for patients who had an antibody titre test performed ] [ Designated as safety issue: No ]
  • Antibody titre findings [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Antibody titre findings [ Time Frame: Year 2 for patients who had an antibody titre test performed ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Year 2 for patients who had an antibody titre test performed ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01538589 on ClinicalTrials.gov Archive Site
  • Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control [ Time Frame: Year 2 for patients who had an antibody titre test performed ] [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Time Frame: Year 2 for patients who had an antibody titre test performed ] [ Designated as safety issue: No ]
  • Total dose of insulin infused subcutaneously [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Total dose of insulin infused subcutaneously [ Time Frame: Year 2 for patients who had an antibody titre test performed ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Special Survey for Patients With Type 1 or Type 2 Diabetes
Special Survey for Type 1 or Type 2 Diabetic Patients

This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients 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
1582
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with no treatment history of insulin aspart (NovoRapid®)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01538589
BIASP-1943
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Masayuki Senda Novo Nordisk Pharma Ltd.
Novo Nordisk A/S
February 2012

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