Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart

Criteria

Inclusion Criteria:

• Type 2 diabetes treated with biphasic human insulin with or without metformin

• Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50

Exclusion Criteria:

• Subjects with diagnosed type 1 diabetes mellitus

• Subjects treated with short acting or intermediate acting human insulin or any insulin analogue

• Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits

• Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients

• Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months