Observational Registry of Basal Insulin Treatment (ORBIT) Study
Insulin treatment is an effective therapy, sometimes the only way to control blood glucose. The progressive loss of ß-cell function in T2DM and the eventual failure of OADs even in combination leads to the need for insulin therapy in many patients.
The scientific use of basal insulin is of great help to individuals and the government for glycemic control. 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, which may contribute to develop related regulations and policies, and guide intelligent use of insulin.
Issue
The resistance and delayed or inadequate use of basal insulin (BI) have been proven to be among the reasons of the bad glycemic control. ORBIT study is therefore designed to evaluate the usage, outcome and safety of initial BI in real world of China, and explore the barriers which impact the use of BI in specific situations, which include but not limited into different region and hospital level.
In particular the objectives are: to assess the effectiveness and safety of initial BI among T2DM patients inadequately controlled by OADs; to describe the initiation and subsequent adjustment of BI regimens, including type, dosage, concomitant OADs, injection method, among T2DM patients uncontrolled with OADs; to compare the effectiveness and safety of the commonly used BI for T2DM patients; to evaluate the disease management of T2DM patients receiving BI regimens; to explore the impact of BI regimens to the quality of life.
Objectives
- Assess the effectiveness and safety of initial basal insulin among T2DM patients inadequately controlled by OADs in real world clinical practice of secondary and tertiary hospitals in China.
- Describe the initiation and subsequent adjustment of basal insulin regimens, including type, dosage, concomitant OADs, injection method, among T2DM patients uncontrolled with OADs in real world clinical practice in China.
Methods
ORBIT is a multicentre, observational, prospective, registry study in China. 200 hospitals from eight regions of China took 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 BI treatment were consecutively enrolled during a 18 months period.
For each participant, interviews were conducted at baseline (zero month), three month and end point (six month) to collect study information including effectiveness and safety, practical use of BI regimens, diabetes management and quality of life.
ORBIT study was launched in late 2011 and the field work was finished in June 2014. 209 hospitals (105 secondary and 104 tertiary) took part in. After preliminary data clean, there are 18995 patients eligible at visit one, 17271 patients completed the visit two with drop-out rate of 9.1%, and 16341 patients completed the visit three with the loss of follow-up rate of 14.0%.
This study has been completed. Further publications are in preparation.
