Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes (UPGRADE)

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00698126

ANA-1897

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.

Enrollment: 4,099 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes
• Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years

Exclusion criteria

• Patients with an end-stage renal failure
• Patients with a serious liver disease
• Patients with concomitant malignant disease

Trial design

4,099 participants in 2 patient groups

A

Treatment:

Drug: soluble human insulin

B

Treatment:

Drug: biphasic insulin aspart