Leili Gao1, Puhong Zhang2, Jianping Weng3, Juming Lu4, Xiaohui Guo5, Weiping Jia6, Wenying Yang7, Dajin Zou8, Zhiguang Zhou9, Changyu Pan4, Yan Gao5, Xian Li2, Dongshan Zhu2, Yangfeng Wu2, Satish K Garg10, Linong Ji1. 1. Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China. 2. Diabetes Program, The George Institute for Global Health at Peking University Health Science Center, Beijing, China. 3. Department of Endocrinology, The First Affiliated Hospital, Division of life sciences and medicine, University of Science and Technology of China, Hefei, China. 4. Department of Endocrinology, The General Hospital of the People's Liberation Army, Beijing, China. 5. Department of Endocrinology, Peking University First Hospital, Beijing, China. 6. Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China. 7. Department of Endocrinology, China-Japan Friendship Hospital, Beijing, China. 8. Department of Endocrinology, The Second Military Medical University, Shanghai, China. 9. Department of Endocrinology, Xiangya Second Hospital, Changsha, China. 10. Barbara Davis Center for Diabetes, University of Colorado Denver, Colorado, Aurora, USA.
Abstract
BACKGROUND: The efficacy of basal insulin (BI) for adequate glycemic control in patients with type 2 diabetes mellitus (T2DM) has been well documented by randomized clinical trials. This post hoc analysis of the Observational Registry of Basal Insulin Treatment (ORBIT) study was performed to explore the 6-month dose of BI used in insulin-naïve T2DM patients achieving HbA1c target (<7%) and determine the patient characteristics that affect the 6-month dose of BI in the setting of real-world clinics in China. METHODS: This multicenter observational registry screened 19 894 adult T2DM patients with inadequately controlled hyperglycemia and treated with oral antidiabetic drugs (OADs) in China. Of these patients, 5191 who continued to receive BI after 6 months and achieved HbA1c target were analyzed. Patient characteristics including age, body weight, fasting plasma glucose (FPG), use of OADs, insulin (type and dose), and glycemic control were recorded at baseline and 6-month follow-ups. RESULTS: The 6-month dose of BI needed for effective glycemic control was 0.20 ± 0.08 U/kg/day. High body mass index, high FPG, young age, longer duration of diabetes or OAD treatment, a greater number of OADs at baseline, and allocation to detemir and glargine were significant independent predictors for high dose of BI at 6 months. CONCLUSIONS: This post hoc analysis of the ORBIT registry provides key information on the 6-month dose of BI needed for effective glycemic control in Chinese T2DM patients. Furthermore, it identified crucial patient characteristics that are significant determinants of the dose of BI in a real-world setting.
BACKGROUND: The efficacy of basal insulin (BI) for adequate glycemic control in patients with type 2 diabetes mellitus (T2DM) has been well documented by randomized clinical trials. This post hoc analysis of the Observational Registry of Basal Insulin Treatment (ORBIT) study was performed to explore the 6-month dose of BI used in insulin-naïve T2DM patients achieving HbA1c target (<7%) and determine the patient characteristics that affect the 6-month dose of BI in the setting of real-world clinics in China. METHODS: This multicenter observational registry screened 19 894 adult T2DM patients with inadequately controlled hyperglycemia and treated with oral antidiabetic drugs (OADs) in China. Of these patients, 5191 who continued to receive BI after 6 months and achieved HbA1c target were analyzed. Patient characteristics including age, body weight, fasting plasma glucose (FPG), use of OADs, insulin (type and dose), and glycemic control were recorded at baseline and 6-month follow-ups. RESULTS: The 6-month dose of BI needed for effective glycemic control was 0.20 ± 0.08 U/kg/day. High body mass index, high FPG, young age, longer duration of diabetes or OAD treatment, a greater number of OADs at baseline, and allocation to detemir and glargine were significant independent predictors for high dose of BI at 6 months. CONCLUSIONS: This post hoc analysis of the ORBIT registry provides key information on the 6-month dose of BI needed for effective glycemic control in Chinese T2DM patients. Furthermore, it identified crucial patient characteristics that are significant determinants of the dose of BI in a real-world setting.