Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: isophane human insulin; Drug: insulin detemir

Study type: Observational

Funder types: Industry

Identifiers

NCT00665808

NN304-1951

Details and patient eligibility

About

This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.

Enrollment: 8,125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent obtained from patient before first documentation of treatment in the observational study.
• Type 2 diabetes mellitus
• Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control
• No contraindication for use of Protaphane® or Levemir®

Exclusion criteria

• None

Trial design

8,125 participants in 2 patient groups

A

Treatment:

Drug: insulin detemir

B

Treatment:

Drug: isophane human insulin