Observational Study to Evaluate the Safety of Levemir® in Diabetes (PREDICTIVE™)

Novo Nordisk

Status: Completed

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

Treatments: Drug: insulin detemir

Study type: Observational

Funder types: Industry

Identifiers

NCT00706017

NN304-3518

Details and patient eligibility

About

This observational study is conducted in North America. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.

Enrollment: 2,282 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or 2 diabetes
• Including newly diagnosed not on insulin or insulin analogue treatment
• Selection at the discretion of the physician
• Adult patients with type 1 and 2 diabetes mellitus, and type 1 patients 6 years and older

Exclusion criteria

• Current treatment with Levemir®
• Previously enrolled in the study
• Hypersensitivity to Levemir®

Trial design

2,282 participants in 1 patient group

A

Treatment:

Drug: insulin detemir