Observational Study of the Predictability of Levemir® in Terms of Metabolic Control, Change of Body Weight and Hypos

Novo Nordisk

Status: Completed

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

Treatments: Drug: insulin aspart; Drug: insulin detemir; Drug: human soluble insulin

Study type: Observational

Funder types: Industry

Identifiers

NCT01542489

NN304-1927

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.

Enrollment: 480 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue insulin detemir (Levemir®) in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)

Trial design

480 participants in 2 patient groups

IDet + IAsp users

Treatment:

Drug: insulin detemir

Drug: insulin aspart

IDet + HI users

Treatment:

Drug: insulin detemir

Drug: human soluble insulin