Status:
COMPLETED
Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
Brief Summary
This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir®...
Eligibility Criteria
Inclusion
- After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label
Exclusion
- Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
- Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
- Subjects who were previously enrolled in this study
- Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
3421 Patients enrolled
Trial Details
Trial ID
NCT00842894
Start Date
May 1 2009
End Date
October 1 2010
Last Update
August 15 2014
Active Locations (1)
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1
Skopje, North Macedonia, MK-1000