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Evaluation of Safety and Parameters of Application Technique

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01516242
First received: January 19, 2012
Last updated: January 24, 2012
Last verified: January 2012

January 19, 2012
January 24, 2012
October 2006
December 2007   (final data collection date for primary outcome measure)
  • Number of insulin applications (punctures) [ Designated as safety issue: No ]
  • Reasons leading to change of the therapy [ Designated as safety issue: No ]
  • Patient satisfaction with NovoPen® 4 insulin delivery system [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01516242 on ClinicalTrials.gov Archive Site
  • Adverse reactions [ Designated as safety issue: No ]
  • Hypoglycaemia [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Safety and Parameters of Application Technique
Monitoring of Expected Parameters of the Application Technique and Safety of the Therapy

This study is conducted in Europe. The aim of the study is to monitor patients changing therapy from syringe to insulin delivery system as prescribed by the treating physician in Slovakia.

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

Patients with type 1 diabetes or type 2 diabetes mellitus treated with insulin having changed administration of inulin from syringe to a Novo Nordisk insulin delivery system

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Delivery Systems
Other: No treatment given
Collection of data about patients with type 1 diabetes or type 2 diabetes treated with insulin changing their insulin administration from syringe to a insulin delivery system based on completion of questionaire
NovoPen® 4
Intervention: Other: No treatment given
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4819
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diabetes mellitus (type 1 or type 2)
  • Treated with insulin
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Slovakia
 
NCT01516242
MS236-1926
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Jozef Lacka, Csc Novo Nordisk Slovakia s.r.o.
Novo Nordisk A/S
January 2012

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