Comparison of the effects on glycaemic control and beta-cell function in newly diagnosed type 2 diabetes patients of treatment with exenatide, insulin or pioglitazone: a multicentre randomized parallel-group trial (the CONFIDENCE study)
单位：[1]Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, the Third Affiliated Hospitalof Sun Yat-sen University, Guangzhou中山大学附属第三医院[2]Department of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical School[3]Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Medical School, Southeast University, Nanjing[4]Department ofEndocrinology, Beijing Hospital of the Ministry of Public Health, Beijing[5]Department of Endocrinology, the First Affiliated Hospital ofNanjing Medical University, Nanjing[6]Department of Endocrinology, the Affiliated Hospital of Guangdong Medical College, Zhanjiang[7]Department of Endocrinology, Affiliated Hospital of Guiyang Medical College, Guizhou[8]Department of Endocrinology, the First AffiliatedHospital, Chongqing Medical University, Chongqing[9]Department of Endocrinology, the Affiliated Hospital of Inner Mongolia MedicalUniversity, Hohhot[10]Department of Endocrinology, the Second Affiliated Hospital of Harbin Medical University, Harbin[11]Department ofEndocrinology, Peking University First Hospital, Beijing[12]Department of Endocrinology, the First Affiliated Hospital of Guangxi MedicalUniversity, Nanning[13]Department of Endocrinology, Chinese People’s Liberation Army General Hospital, Beijing[14]Department ofEndocrinology, the First Affiliated Hospital of China Medical University, Shenyang[15]Department of Endocrinology, China–Japan FriendshipHospital, Beijing[16]Department of Endocrinology and Metabolism, Xijing Hospital affiliated to the Fourth Military Medical University, Xi’an[17]Department of Endocrinology, Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou中山大学附属第二医院[18]Department of Endocrinology, theFirst Affiliated Hospital of Kunming Medical University, Kunming昆明医科大学附属第一医院[19]Department of Endocrinology, Tongji Hospital, Tongji Medical College ofHuazhong University of Science and Technology, Wuhan华中科技大学同济医学院附属同济医院[20]Department of Endocrinology, Qingyuan People’s Hospital, Qingyuan[21]Diabetes Centre, Institute of Metabolism and Endocrinology, the Second Xiangya Hospital and Key Laboratory of Diabetes Immunology,Ministry of Education, Central South University, Changsha[22]Department of Endocrinology, General Hospital of Beijing Military Region,Beijing[23]Department of Endocrinology, First Affiliated Hospital of Shenzhen University, Shenzhen深圳市第二人民医院深圳市康宁医院深圳医学信息中心[24]Department of Endocrinology, the FirstAffiliated Hospital, Shantou University Medical College, Shantou[25]Department of Endocrinology, Peking University People’s Hospital,Beijing, China
ObjectiveProgressive -cell dysfunction hinders the maintenance of glycaemic control in type 2 diabetes, but comparative data on -cell-protective therapies are lacking in the early stage of type 2 diabetes. Here we evaluated the comparative glycaemic efficacy and impact on -cell function of three antihyperglycaemic agents that have a -cell-protective effect, exenatide, insulin and pioglitazone, in newly diagnosed patients with type 2 diabetes. Design and methodsIn this 48-week, multicentre, parallel-group study, 416 patients newly diagnosed with type 2 diabetes were randomly assigned 1:1:1 to receive exenatide, insulin or pioglitazone. The primary end-point was the change in glycosylated haemoglobin (HbA1c) from baseline. Secondary end-points included effects on weight, blood pressure, lipid profiles and -cell function assessed by homeostasis model assessment, fasting proinsulin:insulin (PI/I), disposition index (DI) and acute insulin response (AIR). ResultsAt week 48, mean [95% confidence interval (CI)] HbA(1c) changes from baseline were -1.8% (-1.55% to -2.05%) with exenatide, -1.7% (-1.52% to -1.96%) with insulin and -1.5% (-1.23% to -1.71%) with pioglitazone. Treatment differences were -0.20% (95% CI -0.46% to 0.06%) for exenatide versus insulin (P=0.185), and -0.37% (95% CI -0.63% to -0.12%) for exenatide versus pioglitazone (P=0.002). Significant improvements from baseline in AIR, PI/I and DI were observed with all treatments, with the greatest improvements in DI, as well as weight, blood pressure and lipid profile, observed with exenatide. ConclusionsAll three agents showed efficacy regarding glycaemic control and metabolic benefits; however, exenatide showed the greatest efficacy. -cell function improved in all treatment groups; hence, early initiation of -cell-protective therapy may halt the decline in -cell function in type 2 diabetes.
基金：
Key Projects of Clinical Disciplines of Hospitals Affiliated; National Science Fund for Distinguished Young ScholarsNational Natural Science Foundation of China (NSFC)National Science Fund for Distinguished Young Scholars [81025005]; Eli Lilly and Co.Eli Lilly; Amylin Pharmaceuticals, Inc.Bristol-Myers Squibb; Sun Yat-sen University; Bristol-Myers SquibbBristol-Myers Squibb; Astra ZenecaAstraZeneca
第一作者单位：[1]Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, the Third Affiliated Hospitalof Sun Yat-sen University, Guangzhou
共同第一作者：
通讯作者：
通讯机构：[1]Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, the Third Affiliated Hospitalof Sun Yat-sen University, Guangzhou[25]Department of Endocrinology, Peking University People’s Hospital,Beijing, China[*1]Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, The Third Affiliated Hospital of Sun Yat-sen University, No. 600 Tianhe Road, Guangzhou 510630, China.[*2]Department of Endocrinology, Peking University People’s Hospital, No. 11, Xizhimen South Street, Xicheng District, Beijing 100044, China.
推荐引用方式(GB/T 7714)：
Xu W.,Bi Y.,Sun Z.,et al.Comparison of the effects on glycaemic control and beta-cell function in newly diagnosed type 2 diabetes patients of treatment with exenatide, insulin or pioglitazone: a multicentre randomized parallel-group trial (the CONFIDENCE study)[J].JOURNAL of INTERNAL MEDICINE.2015,277(1):137-150.doi:10.1111/joim.12293.
APA：
Xu, W.,Bi, Y.,Sun, Z.,Li, J.,Guo, L....&Weng, J..(2015).Comparison of the effects on glycaemic control and beta-cell function in newly diagnosed type 2 diabetes patients of treatment with exenatide, insulin or pioglitazone: a multicentre randomized parallel-group trial (the CONFIDENCE study).JOURNAL of INTERNAL MEDICINE,277,(1)
MLA：
Xu, W.,et al."Comparison of the effects on glycaemic control and beta-cell function in newly diagnosed type 2 diabetes patients of treatment with exenatide, insulin or pioglitazone: a multicentre randomized parallel-group trial (the CONFIDENCE study)".JOURNAL of INTERNAL MEDICINE 277..1(2015):137-150
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