Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes (EFFECTIVE)

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

NCT00699179

BIASP-3557

Details and patient eligibility

About

This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.

Enrollment: 2,308 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months
• HbA1c greater than 7%
• Informed Consent

Exclusion criteria

• Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
• Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of months

Trial design

2,308 participants in 1 patient group

A

Treatment:

Drug: biphasic insulin aspart 30