Observational Study on Safety of Self-titration of Once Daily Levemir® (SOLVE™)

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir

Study type: Observational

Funder types: Industry

Identifiers

NCT00740519

NN304-3573

Details and patient eligibility

About

This study is conducted in Europe. The main objective of the study is to assess the safety of self-titration in type 2 diabetic patients on antidiabetic tablets who are receiving insulin for the first time. The study will also look at the blood glucose control, frequency of dose adjustment, clinic visits, and time spent training patients to self-titrate.

The objective of diabetes management is to achieve blood glucose levels as close as possible to normal in order to avoid late stage diabetic complications. Self-titration (where patients adjust insulin dosage themselves) offers the potential for better blood glucose control than titration only at clinic visits. In recent years treatment of type 2 diabetes in the United Kingdom has moved from hospitals to GP surgeries or local clinics. Patients with type 2 diabetes, in general, have not been trained in self-titration to the same degree as patients with type 1 diabetes. Less experience in self-titration could impact the level of blood glucose control and outcome for these patients.

Data from this study will be pooled with data from NN304-3714 (NCT00825643) and will be reported in the final study report for NN304-3714.

Enrollment: 882 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• After the participating physician/nurse's decision has been made to initiate once daily Levemir® therapy (within the license of the product), any patient with type 2 diabetes of 18 years or older who is currently treated with diet, exercise and one or more OADs can be offered to participate

Exclusion criteria

• Patients unable to give written informed consent
• Current treatment with insulin
• Patient deemed unable or unwilling to self-titrate
• Known or suspected allergy to study product or related products
• Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months

Trial design

882 participants in 1 patient group

A

Treatment:

Drug: insulin detemir