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

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir

Study type: Observational

Funder types: Industry

Identifiers

NCT00709475

NN304-3551

Details and patient eligibility

About

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

Enrollment: 747 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

747 participants in 1 patient group

A

Treatment:

Drug: insulin detemir