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NCT01516242 Clinical Trial

Evaluation of Safety and Parameters of Application Technique

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Monitoring of Expected Parameters of the Application Technique and Safety of the Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01516242
Other study ID # MS236-1926
Secondary ID
Status Completed
Phase N/A
First received January 19, 2012
Last updated November 4, 2016
Start date October 2006
Est. completion date December 2007

Study information
Verified date November 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Slovakia: State Institute for Drug Control
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 4819
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Diabetes mellitus (type 1 or type 2)

- Treated with insulin

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Slovakia Novo Nordisk Investigational Site Bratislava

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of insulin applications (punctures) No
Primary Reasons leading to change of the therapy No
Primary Patient satisfaction with NovoPen® 4 insulin delivery system No
Secondary Adverse reactions No
Secondary Hypoglycaemia No
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