Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes

• Status: Completed
• Trial end date: 2008-11-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting

Criteria

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