Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes (INTENSIV)

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart

Study type: Observational

Funder types: Industry

Identifiers

NCT00704223

BIASP-3576

Details and patient eligibility

About

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.

Enrollment: 619 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• HbA1c over 7%
• No contraindication with NovoMix® 70

Exclusion criteria

• Type 1 diabetes
• Subjects participating in a clinical trial or another observational study
• Subjects under previous basis-bolus insulin therapy
• Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method

Trial design

619 participants in 1 patient group

A

Treatment:

Drug: biphasic insulin aspart