Status:
COMPLETED
Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Brief Summary
This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical pra...
Eligibility Criteria
Inclusion
- Type 1 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months
- HbA1c greater than 7%
- Informed Consent
Exclusion
- Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
- Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of months
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
2308 Patients enrolled
Trial Details
Trial ID
NCT00699179
Start Date
June 1 2008
End Date
September 1 2009
Last Update
October 31 2016
Active Locations (1)
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1
Novo Nordisk Investigational Site
Belgrade, Serbia and Montenegro, 11 070