Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Monitoring of Expected Parameters of the Application Technique and Safety of the Therapy
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 |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Slovakia | Novo Nordisk Investigational Site | Bratislava |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Slovakia,
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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