Observational Study on Safety and Efficacy of Biphasic Insulin Aspart in Type 2 Diabetes Patients

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart 70; Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 50

Study type: Observational

Funder types: Industry

Identifiers

NCT00834262

BIASP-3669

Details and patient eligibility

About

This study is conducted in Asia. The aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.

Enrollment: 339 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible

Exclusion criteria

• Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label.
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.

Trial design

339 participants in 1 patient group

A

Treatment:

Drug: biphasic insulin aspart 50

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 70