Linong Ji1,2, Puhong Zhang2, Dongshan Zhu2, Juming Lu3, Xiaohui Guo4, Yangfeng Wu2, Xian Li5, Jiachao Ji5, Weiping Jia6, Wenying Yang7, Dajin Zou8, Zhiguang Zhou9, Yan Gao4, Satish K Garg10, Changyu Pan3, Jianping Weng11, Sanjoy K Paul12. 1. Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, P.R. China. 2. Diabetes Research Program, The George Institute for Global Health at Peking University Health Science Center, Beijing, P.R. China. 3. Department of Endocrinology, The General Hospital of the People's Liberation Army, Beijing, P.R. China. 4. Department of Endocrinology, Peking University First Hospital, Beijing, P.R. China. 5. Biostatistics and Economic Evaluation Program, The George Institute for Global Health at Peking University Health Science Center, Beijing, P.R. China. 6. Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, P.R. China. 7. Department of Endocrinology, China-Japan Friendship Hospital, Beijing, P.R. China. 8. Department of Endocrinology, The Second Military Medical University, Shanghai, P.R. China. 9. Department of Endocrinology, Xiangya Second Hospital, Changsha, P.R. China. 10. Barbara Davis Center for Diabetes, University of Colorado Denver, Aurora, Colorado. 11. Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, P.R. China. 12. Melbourne EpiCentre, University of Melbourne, Melbourne, Australia.
Abstract
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.
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 diabetespatients. However, the clinical relevance of these observations must be interpreted with caution.
Authors: Christina M Gant; Ijmke Mensink; S Heleen Binnenmars; Job A M van der Palen; Stephan J L Bakker; Gerjan Navis; Gozewijn D Laverman Journal: PLoS One Date: 2019-06-19 Impact factor: 3.240