Linong Ji1,2, Puhong Zhang2, Jianping Weng3, Juming Lu4, Xiaohui Guo1, Weiping Jia5, Wenying Yang6, Dajin Zou7, Zhiguang Zhou8, Changyu Pan9, Yan Gao1, Xian Li2, Dongshan Zhu2, Ying Li2, Yangfeng Wu2, Satish K Garg10. 1. 1 Peking University People's Hospital , Beijing, China . 2. 2 The George Institute for Global Health at Peking University Health Science Center , Beijing, China . 3. 3 The Third Affiliated Hospital of Sun Yat-sen University , Guangzhou, China . 4. 4 Chinese PLA General Hospital , Beijing, China . 5. 5 Shanghai 6th Hospital , Shanghai, China . 6. 6 China-Japan Friendship Hospital , Beijing, China . 7. 7 The Second Military Medical University , Shanghai, China . 8. 8 Xiangya Second Hospital , Changsha, Hunan, China . 9. 9 Beijing 301 Military General Hospital , Beijing, China . 10. 10 Barbara Davis Center for Diabetes, University of Colorado Denver , Aurora, Colorado.
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. 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 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.
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 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: Lawrence Blonde; Pablo Aschner; Clifford Bailey; Linong Ji; Lawrence A Leiter; Stephan Matthaei Journal: Diab Vasc Dis Res Date: 2017-02-01 Impact factor: 3.291