Observational Registry of Basal Insulin Treatment (ORBIT) in patients with type 2 diabetes uncontrolled by oral hypoglycemic agents in China—study design and baseline characteristics

Background: Efficacy of basal insulin (BI) has been well studied by randomized controlled trials, but the impact of BI on glycemic control in the real world has not been well documented. The Observational Registry for BI Treatment (ORBIT) study is designed to evaluate the real-life outcomes of BI in China.Materials and Methods: Participants with type 2 diabetes (n=19,894), from December 2011 to June 2013, inadequately controlled on oral hypoglycemic agents (OHAs) were initiated on BI treatment from 209 hospitals in all the eight regions in Mainland China. Data for each patient on use of OHAs and insulin (type and dose), glycemic control, hypoglycemic episodes, body weight, quality of life, and costs were collected at baseline and 3 and 6 months.Results: For the 18,995 participants who were eligible for baseline analysis, mean +/- SD age was 55.4 +/- 10.4 years, with 52.5% males. The mean duration of diabetes was 6.4 +/- 5.3 years and was positively associated with the economic level of eight regions. Before initiation of BI, patients had a mean hemoglobin A1c level of 9.6 +/- 2.0% with a fasting plasma glucose level of 11.7 +/- 4.0 mmol/L. Of the patients, 35.5% had some diabetes complications. Metformin, sulfonylureas, and alpha-glycosidase inhibitors were the most commonly used OHAs. The proportions of patients using one, two, or more than two OHAs before BI initiation were 48.4%, 42.7%, and 8.9%, respectively.Conclusions: To the best of our knowledge, the ORBIT study is the largest registry study to evaluate glycemic outcomes and safety of BI in real-world China. Baseline data indicate delays in initiation of BI in the majority of patients with type 2 diabetes in China