Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes (IMPROVE™)

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart

Study type: Observational

Funder types: Industry

Identifiers

NCT00659282

BIASP-1766

Details and patient eligibility

About

This study is conducted in Asia, Europe, Japan and North America. The aim of this observational study is to evaluate the safety and effectiveness while using NovoMix® 30 during 26 weeks under normal clinical practice, in the countries participating in the study. The primary outcome is the incidence of major hypoglycaemic events reported as serious adverse drugs reaction conditions on hypoglycaemic events.

Enrollment: 57,610 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age according to approved label and physician discretion
• Type 2 diabetes including newly-diagnosed subjects who have never received insulin or an insulin analogue before

Exclusion criteria

• Subjects who previously enrolled in this study
• Subjects who are unlikely to comply with protocol requirements
• Hypersensitivity to biphasic insulin aspart or to any of the excipients
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Trial design

57,610 participants in 1 patient group

A

Description:

biphasic insulin aspart

Treatment:

Drug: biphasic insulin aspart