title: Comparative effectiveness and safety of different basal insulins in a real-world setting.
abstract: To compare glucose control and safety of different basal insulin therapies (BI, including Insulin NPH, glargine and detemir) in real-world clinical settings based on a large-scale registry study.
  
  
  
  In this multi-center 6-month prospective observational study, patients with type 2 diabetes (HbA1c ≥ 7%) who were uncontrolled by oral anti-diabetic drugs (OADs) and were willing to initiate BI therapy were enrolled from 209 hospitals within 8 regions of China. Type and dose of BI were at the physician's discretion and the patients' willingness. Interviews were conducted at 0 months (visit 1), 3 months (visit 2) and 6 months (visit 3). Outcomes included change in HbA1c, hypoglycemia rate and body weight from baseline at 6 months.
  
  
  
  A total of 16 341 and 9002 subjects were involved in Intention-To-Treat (ITT) and per-protocol (PP) analysis, respectively. After PS regression adjustment, ITT analysis showed that reduction in HbA1c in glargine (2.2% ± 2.1%) and detemir groups (2.2% ± 2.1%) was higher than that in the NPH group (2.0% ± 2.2%) (P < .01). The detemir group had the lowest weight gain (-0.1 ± 2.9 kg) compared with the glargine (+0.1 ± 3.0 kg) and NPH (+0.3 ± 3.1 kg) groups (P < .05). The glargine group had the lowest rate of minor hypoglycaemia, while there was no difference in severe hypoglycaemia among the 3 groups. The results observed in PP analyses were consistent with those in ITT analysis.
  
  
  
  In a real-world clinical setting in China, treatment with long-acting insulin analogues was associated with better glycaemic control, as well as less hypoglycaemia and weight gain than treatment with NPH insulin in type 2 diabetes patients. However, the clinical relevance of these observations must be interpreted with caution.
authors.affiliation: Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, P.R. China.|Diabetes Research Program, The George Institute for Global Health at Peking University Health Science Center, Beijing, P.R. China.
authors.forename: Linong
authors.initials: L
authors.lastname: Ji
authors.affiliation: Diabetes Research Program, The George Institute for Global Health at Peking University Health Science Center, Beijing, P.R. China.
authors.forename: Puhong
authors.initials: P
authors.lastname: Zhang
authors.affiliation: Diabetes Research Program, The George Institute for Global Health at Peking University Health Science Center, Beijing, P.R. China.
authors.forename: Dongshan
authors.initials: D
authors.lastname: Zhu
authors.affiliation: Department of Endocrinology, The General Hospital of the People's Liberation Army, Beijing, P.R. China.
authors.forename: Juming
authors.initials: J
authors.lastname: Lu
authors.affiliation: Department of Endocrinology, Peking University First Hospital, Beijing, P.R. China.
authors.forename: Xiaohui
authors.initials: X
authors.lastname: Guo
authors.affiliation: Diabetes Research Program, The George Institute for Global Health at Peking University Health Science Center, Beijing, P.R. China.
authors.forename: Yangfeng
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Biostatistics and Economic Evaluation Program, The George Institute for Global Health at Peking University Health Science Center, Beijing, P.R. China.
authors.forename: Xian
authors.initials: X
authors.lastname: Li
authors.affiliation: Biostatistics and Economic Evaluation Program, The George Institute for Global Health at Peking University Health Science Center, Beijing, P.R. China.
authors.forename: Jiachao
authors.initials: J
authors.lastname: Ji
authors.affiliation: Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, P.R. China.
authors.forename: Weiping
authors.initials: W
authors.lastname: Jia
authors.affiliation: Department of Endocrinology, China-Japan Friendship Hospital, Beijing, P.R. China.
authors.forename: Wenying
authors.initials: W
authors.lastname: Yang
authors.affiliation: Department of Endocrinology, The Second Military Medical University, Shanghai, P.R. China.
authors.forename: Dajin
authors.initials: D
authors.lastname: Zou
authors.affiliation: Department of Endocrinology, Xiangya Second Hospital, Changsha, P.R. China.
authors.forename: Zhiguang
authors.initials: Z
authors.lastname: Zhou
authors.affiliation: Department of Endocrinology, Peking University First Hospital, Beijing, P.R. China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Gao
authors.affiliation: Barbara Davis Center for Diabetes, University of Colorado Denver, Aurora, Colorado.
authors.forename: Satish K
authors.initials: SK
authors.lastname: Garg
authors.affiliation: Department of Endocrinology, The General Hospital of the People's Liberation Army, Beijing, P.R. China.
authors.forename: Changyu
authors.initials: C
authors.lastname: Pan
authors.affiliation: Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, P.R. China.
authors.forename: Jianping
authors.initials: J
authors.lastname: Weng
authors.affiliation: Melbourne EpiCentre, University of Melbourne, Melbourne, Australia.
authors.forename: Sanjoy K
authors.initials: SK
authors.lastname: Paul
mesh_terms: D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D016903:Drug Monitoring; D004351:Drug Resistance; D004359:Drug Therapy, Combination / Q000009:adverse effects; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000503:physiopathology / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069057:Insulin Detemir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D057194:Intention to Treat Analysis; D059012:Lost to Follow-Up; D011446:Prospective Studies; D012042:Registries; D012720:Severity of Illness Index; D015430:Weight Gain / Q000187:drug effects
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069057:Insulin Detemir; D000069036:Insulin Glargine; D007336:Insulin, Isophane; C517652:hemoglobin A1c protein, human
keywords: basal insulin; glycaemic control; type 2 diabetes