Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir; Drug: biphasic insulin aspart 30

Study type: Observational

Funder types: Industry

Identifiers

NCT00842894

NN304-3716

Details and patient eligibility

About

This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.

Enrollment: 3,421 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• After the physician decision has been made to use biphasic insulin aspart 30 or 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.Particular attention should be paid to the drug interactions that are listed within the product label

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 biphasic insulin aspart 30 or insulin detemir
• Subjects who were previously enrolled in this study
• Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Trial design

3,421 participants in 2 patient groups

Insulin detemir

Treatment:

Drug: insulin detemir

Biphasic insulin aspart 30

Treatment:

Drug: biphasic insulin aspart 30