Status:
COMPLETED
Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic Agents
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief Summary
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin...
Eligibility Criteria
Inclusion
- Type 2 diabetes for at least 12 months and currently receiving oral anti-diabetic (OAD) treatment, whether single or combination, for at least 3 months before this study
- Insulin naive
- Poor glycaemic control on OADs and decided by the physician to start insulin therapy
Exclusion
- Type 1 diabetes patients
- Patients who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
- Patients with a hypersensitivity to insulin or to any of the excipients
- Patient groups not approved in the product label
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
1667 Patients enrolled
Trial Details
Trial ID
NCT00715780
Start Date
June 1 2008
End Date
July 1 2009
Last Update
November 7 2016
Active Locations (1)
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1
Novo Nordisk Investigational Site
Jakarta, Indonesia, 12520