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

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart 50

Study type: Observational

Funder types: Industry

Identifiers

NCT00755833

BIASP-3674

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

270 participants in 1 patient group

A

Treatment:

Drug: biphasic insulin aspart 50