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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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, Isophane

Criteria

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