单位:[1]Department of Endocrinology andMetabolism, Peking University People’sHospital, Beijing, P.R. China[2]Diabetes Research Program, The GeorgeInstitute for Global Health at PekingUniversity Health Science Center, Beijing, P.R.China[3]Department of Endocrinology, The GeneralHospital of the People’s Liberation Army,Beijing, P.R. China[4]Department of Endocrinology, PekingUniversity First Hospital, Beijing, P.R. China[5]Biostatistics and Economic EvaluationProgram, The George Institute for GlobalHealth at Peking University Health ScienceCenter, Beijing, P.R. China[6]Department of Endocrinology andMetabolism, Shanghai Jiao Tong UniversityAffiliated Sixth People’s Hospital, Shanghai, P.R. China[7]Department of Endocrinology, China-JapanFriendship Hospital, Beijing, P.R. China[8]Department of Endocrinology, The SecondMilitary Medical University, Shanghai, P.R.China[9]Department of Endocrinology, XiangyaSecond Hospital, Changsha, P.R. China[10]Barbara Davis Center for Diabetes,University of Colorado Denver, Aurora,Colorado[11]Department of Endocrinology, The ThirdAffiliated Hospital of Sun Yat-sen University,Guangzhou, P.R. China[12]Melbourne EpiCentre, University ofMelbourne, Melbourne, Australia
Aims: 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. Methods: 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. Results: 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. Conclusion: 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.
第一作者单位:[1]Department of Endocrinology andMetabolism, Peking University People’sHospital, Beijing, P.R. China[2]Diabetes Research Program, The GeorgeInstitute for Global Health at PekingUniversity Health Science Center, Beijing, P.R.China[*1]Department of Endocrinology and Metabolism, Peking University People’s Hospital, No. 11, Xizhimen Nan Da Jie, Xicheng District, Beijing 100044, P.R. China.
通讯作者:
通讯机构:[1]Department of Endocrinology andMetabolism, Peking University People’sHospital, Beijing, P.R. China[2]Diabetes Research Program, The GeorgeInstitute for Global Health at PekingUniversity Health Science Center, Beijing, P.R.China[3]Department of Endocrinology, The GeneralHospital of the People’s Liberation Army,Beijing, P.R. China[*1]Department of Endocrinology and Metabolism, Peking University People’s Hospital, No. 11, Xizhimen Nan Da Jie, Xicheng District, Beijing 100044, P.R. China.[*2]Department of Endocrinology, The General Hospital of the People’s Liberation Army, No.28, Fuxing Road, Haidian District, Beijing 100853, P.R. China.
推荐引用方式(GB/T 7714):
Ji Linong,Zhang Puhong,Zhu Dongshan,et al.Comparative effectiveness and safety of different basal insulins in a real-world setting[J].DIABETES OBESITY & METABOLISM.2017,19(8):1116-1126.doi:10.1111/dom.12920.
APA:
Ji, Linong,Zhang, Puhong,Zhu, Dongshan,Lu, Juming,Guo, Xiaohui...&on behalf of the ORBIT study group.(2017).Comparative effectiveness and safety of different basal insulins in a real-world setting.DIABETES OBESITY & METABOLISM,19,(8)
MLA:
Ji, Linong,et al."Comparative effectiveness and safety of different basal insulins in a real-world setting".DIABETES OBESITY & METABOLISM 19..8(2017):1116-1126