Status:
COMPLETED
Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
6+ years
Brief Summary
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice condition...
Eligibility Criteria
Inclusion
- After the physician decision has been made to use 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. The selection of the subjects will be at the discretion of the individual physician
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 insulin detemir;
- Subjects who previously enrolled in this study or studies related to NovoMix 30;
- Subjects with a hypersensitivity to insulin detemir or to any of the excipients;
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
747 Patients enrolled
Trial Details
Trial ID
NCT00709475
Start Date
May 1 2008
End Date
October 1 2009
Last Update
October 28 2016
Active Locations (1)
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1
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia, 3542