Overview

Observational Safety Study in Subjects Using LevemirĀ® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
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 conditions in the Gulf countries
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin Detemir
Insulin, Globin Zinc
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.