Observational Study on Efficacy and Safety in Patients Using NovoMix® 30 for the Treatment of Diabetes (UPGRADE)

Novo Nordisk

Status: Completed

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

Treatments: Drug: biphasic insulin aspart 30

Study type: Observational

Funder types: Industry

Identifiers

NCT00737776

BIASP-3547

Details and patient eligibility

About

This study is conducted in Asia. The aim of this observational study is to evaluate the efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated.

Enrollment: 1,068 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30
• Patient who signed on informed consent form

Exclusion criteria

• Patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
• Patients who were previously enrolled in this study
• Patients with a hypersensitivity to NovoMix® 30 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

1,068 participants in 1 patient group

A

Treatment:

Drug: biphasic insulin aspart 30