Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic Agents

Novo Nordisk

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00715780

INS-3615

Details and patient eligibility

About

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. The switch from OAD treatment to insulin therapy will be determined by physician.

Enrollment: 1,667 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes for at least 12 months and currently receiving oral anti-diabetic (OAD) treatment, whether single or combination, for at least 3 months before this study
• Insulin naive
• Poor glycaemic control on OADs and decided by the physician to start insulin therapy

Exclusion criteria

• Type 1 diabetes patients
• Patients who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
• Patients with a hypersensitivity to insulin or to any of the excipients
• Patient groups not approved in the product label

Trial design

1,667 participants in 1 patient group

A

Treatment:

Drug: insulin aspart

Drug: biphasic human insulin

Drug: biphasic insulin aspart

Drug: soluble human insulin

Drug: insulin detemir

Drug: insulin NPH