Comparison of the effects on glycaemic control and β-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)

被引:56
作者
Xu, W. [1 ]
Bi, Y. [2 ]
Sun, Z. [3 ]
Li, J. [1 ]
Guo, L. [4 ]
Yang, T. [5 ]
Wu, G. [6 ]
Shi, L. [7 ]
Feng, Z. [8 ]
Qiu, L. [9 ]
Li, Q. [10 ]
Guo, X. [11 ]
Luo, Z. [12 ]
Lu, J. [13 ]
Shan, Z. [14 ]
Yang, W. [15 ]
Ji, Q. [16 ]
Yan, L. [17 ]
Li, H. [18 ]
Yu, X. [19 ]
Li, S. [20 ]
Zhou, Z. [21 ,22 ]
Lv, X. [23 ]
Liang, Z. [24 ]
Lin, S. [25 ]
Zeng, L. [1 ]
Yan, J. [1 ]
Ji, L. [26 ]
Weng, J. [1 ]
机构
[1] Sun Yat Sen Univ, Affiliated Hosp 3, Guangdong Prov Key Lab Diabetol, Dept Endocrinol & Metab, Guangzhou 510630, Guangdong, Peoples R China
[2] Nanjing Univ, Med Sch, Drum Tower Hosp, Dept Endocrinol, Nanjing 210008, Jiangsu, Peoples R China
[3] Southeast Univ, Sch Med, Inst Diabet, Dept Endocrinol,Zhongda Hosp, Nanjing, Jiangsu, Peoples R China
[4] Minist Publ Hlth, Beijing Hosp, Dept Endocrinol, Beijing, Peoples R China
[5] Nanjing Med Univ, Affiliated Hosp 1, Dept Endocrinol, Nanjing, Jiangsu, Peoples R China
[6] Guangdong Med Coll, Affiliated Hosp, Dept Endocrinol, Zhanjiang, Peoples R China
[7] Guiyang Med Coll, Affiliated Hosp, Dept Endocrinol, Guiyang, Guizhou, Peoples R China
[8] Chongqing Med Univ, Affiliated Hosp 1, Dept Endocrinol, Chongqing, Peoples R China
[9] Inner Mongolia Med Univ, Affiliated Hosp, Dept Endocrinol, Hohhot, Peoples R China
[10] Harbin Med Univ, Affiliated Hosp 2, Dept Endocrinol, Harbin, Peoples R China
[11] Peking Univ, Hosp 1, Dept Endocrinol, Beijing 100871, Peoples R China
[12] Guangxi Med Univ, Affiliated Hosp 1, Dept Endocrinol, Nanning, Peoples R China
[13] Chinese Peoples Liberat Army Gen Hosp, Dept Endocrinol, Beijing, Peoples R China
[14] China Med Univ, Affiliated Hosp 1, Dept Endocrinol, Shenyang, Peoples R China
[15] China Japan Friendship Hosp, Dept Endocrinol, Beijing, Peoples R China
[16] Fourth Mil Med Univ, Xijing Hosp, Dept Endocrinol & Metab, Xian 710032, Peoples R China
[17] Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dept Endocrinol, Guangzhou 510275, Guangdong, Peoples R China
[18] Kunming Med Univ, Affiliated Hosp 1, Dept Endocrinol, Kunming, Peoples R China
[19] Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Dept Endocrinol, Wuhan 430074, Peoples R China
[20] Qingyuan Peoples Hosp, Dept Endocrinol, Qingyuan, Peoples R China
[21] Cent South Univ, Xiangya Hosp 2, Inst Metab & Endocrinol, Ctr Diabet, Changsha, Hunan, Peoples R China
[22] Cent South Univ, Minist Educ, Key Lab Diabet Immunol, Changsha, Hunan, Peoples R China
[23] Gen Hosp Beijing Mil Reg, Dept Endocrinol, Beijing, Peoples R China
[24] Shenzhen Univ, Affiliated Hosp 1, Dept Endocrinol, Shenzhen, Peoples R China
[25] Shantou Univ, Coll Med, Affiliated Hosp 1, Dept Endocrinol, Shantou, Peoples R China
[26] Peking Univ, Peoples Hosp, Dept Endocrinol, Beijing 100871, Peoples R China
关键词
-cell function; exenatide; glucose; insulin; pioglitazone; FASTING PLASMA-GLUCOSE; METFORMIN; EFFICACY; GLARGINE; SAFETY; TWICE; PRESERVATION; SITAGLIPTIN; MONOTHERAPY; MANAGEMENT;
D O I
10.1111/joim.12293
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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收藏
页码:137 / 150
页数:14
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