Observational Study to Evaluate the Safety While Using Levemir®

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir

Study type: Observational

Funder types: Industry

Identifiers

NCT00701155

NN304-1953

Details and patient eligibility

About

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions in Egypt.

Enrollment: 3,593 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• After the physician decision has been made to use insulin detemir, any subject with Type 1 or Type 2 diabetes mellitus 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
• Subjects with a hypersensitivity to insulin detemir or to any of the excipients
• Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. (Adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)

Trial design

3,593 participants in 1 patient group

A

Treatment:

Drug: insulin detemir