Observational Registry for Basal Insulin Treatment Study (ORBIT)

The George Institute for Global Health, China

Status: Completed

Conditions: Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT01859598

ORBIT

Details and patient eligibility

About

The scientific use of basal insulin is of great help to individuals and the government. However, there are few studies to investigate the real world use, effect, safety and influence factors of basal insulin in China. This study is to evaluate the use of first basal insulin in China patients with type 2 diabetes with inadequate glycemic control on oral antidiabetic agents (OADs) from the naturalistic clinical practice.

Full description

This is a 6-month multicentre, observational, prospective, registry study. About 200 hospitals from different parts of China will take part in this study, and about 20,000 patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with OADs and willing to accept basal insulin (BI) treatment will be consecutively enrolled during a 12 months period.

The study participants will include at baseline (0 month), 3 month and end point (6 month) to collect the study information. The project will probably last for about 18 months.

Enrollment: 19,894 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 years old
• Type 2 diabetic patients
• Taking OADs before inclusion
• Recently tested HbA1c >=7% at the same site within 3 months
• Being suggested by physician to start basal insulin (BI) treatment
• Willing to start and having been prescribed BI treatment
• Willing to join the registry study and sign the informed consent

Exclusion criteria

• Diagnosed with type 1 diabetes
• Received any type of insulin in the last 2 years (except for the intermittent use of insulin of less than 1 month each time)
• With any severe health problem, or any other situation judged by the investigator, that is difficult for the 6 months follow-up
• Current or planned pregnant, lactating women
• Involved in other clinical trial simultaneously or at most 1 month before