Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart 30; Drug: insulin detemir; Drug: insulin aspart

Study type: Observational

Funder types: Industry

Identifiers

NCT00670722

NN304-3517

Details and patient eligibility

About

This study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.

Enrollment: 6,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Current treatment with human soluble insulin, insulin NPH or premixed human insulin
• The selection of the subjects will be at the discretion of the individual physician

Exclusion criteria

• Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30
• Previous enrolment in this study
• Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients.
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir

Trial design

6,500 participants in 4 patient groups

A

Treatment:

Drug: insulin aspart

B

Treatment:

Drug: insulin detemir

C

Treatment:

Drug: biphasic insulin aspart 30

D

Treatment:

Drug: insulin aspart

Drug: insulin detemir