Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard® (EVIDENCE)

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir; Drug: insulin NPH

Study type: Observational

Funder types: Industry

Identifiers

NCT00658099

NN304-1976

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.

Enrollment: 699 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• HbA1c greater than 7.0% and/or hypoglycaemia
• variable FBG and/or weight increase
• the selection of the subjects will be at the discretion of the participating physician

Exclusion criteria

• non-type 2 diabetes
• current treatment with Levemir® or Insulatard®
• hypersensitivity to Levemir® or Insulatard® 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

699 participants in 2 patient groups

A

Treatment:

Drug: insulin detemir

B

Treatment:

Drug: insulin NPH