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Comparative effectiveness and safety of different basal insulins in a real‐world setting
Author(s) -
Ji Lig,
Zhang Puhong,
Zhu Dongshan,
Lu Juming,
Guo Xiaohui,
Wu Yangfeng,
Li Xian,
Ji Jiachao,
Jia Weiping,
Yang Wenying,
Zou Dajin,
Zhou Zhiguang,
Gao Yan,
Garg Satish K.,
Pan Changyu,
Weng Jianping,
Paul Sanjoy K.
Publication year - 2017
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12920
Subject(s) - medicine , hypoglycemia , observational study , insulin glargine , type 2 diabetes , diabetes mellitus , basal (medicine) , pediatrics , insulin , endocrinology
Aims To compare glucose control and safety of different basal insulin therapies ( BI , including I nsulin 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 C hina. 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 I ntention‐ T o‐ T reat ( 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 C hina, 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.