Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart 30

Study type: Observational

Funder types: Industry

Identifiers

NCT00709683

BIASP-3572

Details and patient eligibility

About

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.

Enrollment: 216 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes having failed on basal insulin with or without OAD
• HbA1c greater than 7.0%

Exclusion criteria

• Subjects being unlikely to comply with protocol requirements
• Subjects who previously enrolled in this study
• Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
• Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method

Trial design

216 participants in 1 patient group

A

Treatment:

Drug: biphasic insulin aspart 30