Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes (IDEALS)

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir

Study type: Observational

Funder types: Industry

Identifiers

NCT00700830

NN304-3571

Details and patient eligibility

About

This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.

Enrollment: 1,976 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any trial-related activities
• Type 2 diabetes
• HbA1c between 7-9%
• Insulin naive
• Inadequate control with oral antidiabetics therapy as judged by investigator

Exclusion criteria

• Patients with type 1 diabetes
• Hypersensitivity to Levemir® or to any of the excipients
• Pregnancy, or desire of pregnancy within next 6 months
• HbA1c greater than or equal to 9%
• Known or suspected allergy to the trial product or to any of the excipients
• Subjects who are unlikely to comply with protocol

Trial design

1,976 participants in 1 patient group

A

Treatment:

Drug: insulin detemir