An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00698269

INS-3532

Details and patient eligibility

About

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.

Enrollment: 5,926 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or type 2 diabetes
• Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
• Selection will be at the discretion of the individual physician

Exclusion criteria

• Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
• Previous enrolled in this study
• Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Trial design

5,926 participants in 3 patient groups

A

Treatment:

Drug: insulin detemir

B

Treatment:

Drug: biphasic insulin aspart 30

C

Treatment:

Drug: insulin aspart