title: 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.
abstract: 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.
  
  
  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 α-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.
authors.affiliation: 1 Peking University People's Hospital , Beijing, China .|2 The George Institute for Global Health at Peking University Health Science Center , Beijing, China .
authors.forename: Linong
authors.initials: L
authors.lastname: Ji
authors.affiliation: 2 The George Institute for Global Health at Peking University Health Science Center , Beijing, China .
authors.forename: Puhong
authors.initials: P
authors.lastname: Zhang
authors.affiliation: 3 The Third Affiliated Hospital of Sun Yat-sen University , Guangzhou, China .
authors.forename: Jianping
authors.initials: J
authors.lastname: Weng
authors.affiliation: 4 Chinese PLA General Hospital , Beijing, China .
authors.forename: Juming
authors.initials: J
authors.lastname: Lu
authors.affiliation: 1 Peking University People's Hospital , Beijing, China .
authors.forename: Xiaohui
authors.initials: X
authors.lastname: Guo
authors.affiliation: 5 Shanghai 6th Hospital , Shanghai, China .
authors.forename: Weiping
authors.initials: W
authors.lastname: Jia
authors.affiliation: 6 China-Japan Friendship Hospital , Beijing, China .
authors.forename: Wenying
authors.initials: W
authors.lastname: Yang
authors.affiliation: 7 The Second Military Medical University , Shanghai, China .
authors.forename: Dajin
authors.initials: D
authors.lastname: Zou
authors.affiliation: 8 Xiangya Second Hospital , Changsha, Hunan, China .
authors.forename: Zhiguang
authors.initials: Z
authors.lastname: Zhou
authors.affiliation: 9 Beijing 301 Military General Hospital , Beijing, China .
authors.forename: Changyu
authors.initials: C
authors.lastname: Pan
authors.affiliation: 1 Peking University People's Hospital , Beijing, China .
authors.forename: Yan
authors.initials: Y
authors.lastname: Gao
authors.affiliation: 2 The George Institute for Global Health at Peking University Health Science Center , Beijing, China .
authors.forename: Xian
authors.initials: X
authors.lastname: Li
authors.affiliation: 2 The George Institute for Global Health at Peking University Health Science Center , Beijing, China .
authors.forename: Dongshan
authors.initials: D
authors.lastname: Zhu
authors.affiliation: 2 The George Institute for Global Health at Peking University Health Science Center , Beijing, China .
authors.forename: Ying
authors.initials: Y
authors.lastname: Li
authors.affiliation: 2 The George Institute for Global Health at Peking University Health Science Center , Beijing, China .
authors.forename: Yangfeng
authors.initials: Y
authors.lastname: Wu
authors.affiliation: 10 Barbara Davis Center for Diabetes, University of Colorado Denver , Aurora, Colorado.
authors.forename: Satish K
authors.initials: SK
authors.lastname: Garg
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012042:Registries; D012107:Research Design
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin