NCT01859598

Observational Registry for Basal Insulin Treatment Study (ORBIT)

A Prospective, Observational Registry Study Focusing on the Real World Use, Effectiveness and Safety of Initial Basal Insulin Regimen in Type 2 Diabetic Patients Uncontrolled by Oral Antidiabetic Drugs in China

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19,894 (actual)
• Sponsor: The George Institute for Global Health, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Diabetes

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-05-22
• Last updated: 2016-10-12
• Results posted: 2016-10-12

Locations

2 sites across 1 country: China