Observational Study to Evaluate the Safety of Levemir® in Type 2 Diabetes (SOLVE™)

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir

Study type: Observational

Funder types: Industry

Identifiers

NCT00825643

NN304-3714

Details and patient eligibility

About

This study is conducted in Europe, North America and Asia. The aim of this observational study is to evaluate the safety and effectiveness while using Levemir® once daily in combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal clinical practice.

Data from the NN304-3573 study (NCT00740519) will be pooled with data from this study and reported together in the final study report for this study.

Enrollment: 18,481 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• After the participating physician's decision has been made to initiate once-daily Levemir® therapy, any patient with Type 2 diabetes who is currently treated with diet, exercise and one or more OADs can be offered to participate

Exclusion criteria

• Current treatment with insulin
• Known or suspected allergy to Levemir® or excipients
• Children below the age of 6 years
• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 6 months or are not using adequate contraceptive methods (contraceptive measures as required by local law or practice)

Trial design

18,481 participants in 1 patient group

Insulin detemir

Treatment:

Drug: insulin detemir