These authors contributed equally.
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)
Article first published online: 5 AUG 2014
© 2014 The Association for the Publication of the Journal of Internal Medicine
Journal of Internal Medicine
Volume 277, Issue 1, pages 137–150, January 2015
How to Cite
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). J Intern Med 2015; 277: 137–150., , , , , , , , , , , , , , , , , , , , , , , , , , , , (The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou; Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing; Zhongda Hospital, Institute of Diabetes, Medical School, Southeast University, Nanjing; Beijing Hospital of the Ministry of Public Health, Beijing; The First Affiliated Hospital of Nanjing Medical University, Nanjing; The Affiliated Hospital of Guangdong Medical College, Zhanjiang; Affiliated Hospital of Guiyang Medical College, Guizhou; The First Affiliated Hospital, Chongqing Medical University, Chongqing; The Affiliated Hospital of Inner Mongolia Medical University, Hohhot; The Second Affiliated Hospital of Harbin Medical University, Harbin; Peking University First Hospital, Beijing; The First Affiliated Hospital of Guangxi Medical University, Nanning; Chinese People's Liberation Army General Hospital, Beijing; The First Affiliated Hospital of China Medical University, Shenyang; China–Japan Friendship Hospital, Beijing; Xijing Hospital affiliated to the Fourth Military Medical University, Xi'an; Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou; The First Affiliated Hospital of Kunming Medical University, Kunming; Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan; Qingyuan People's Hospital, Qingyuan; Diabetes Centre, Institute of Metabolism and Endocrinology, the Second Xiangya Hospital and Key Laboratory of Diabetes Immunology, Ministry of Education, Central South University, Changsha; General Hospital of Beijing Military Region, Beijing; First Affiliated Hospital of Shenzhen University, Shenzhen; The First Affiliated Hospital, Shantou University Medical College, Shantou; and Peking University People's Hospital, Beijing; China).
- Issue published online: 15 DEC 2014
- Article first published online: 5 AUG 2014
- Accepted manuscript online: 16 JUL 2014 02:10AM EST
- Ministry of Health of the People's Republic of China
- National Science Fund. Grant Number: 81025005
- Eli Lilly and Co.
- Amylin Pharmaceuticals, Inc.
- Bristol-Myers Squibb
- Astra Zeneca
- β-cell function;
Progressive β-cell dysfunction hinders the maintenance of glycaemic control in type 2 diabetes, but comparative data on β-cell-protective therapies are lacking in the early stage of type 2 diabetes. Here we evaluated the comparative glycaemic efficacy and impact on β-cell function of three antihyperglycaemic agents that have a β-cell-protective effect, exenatide, insulin and pioglitazone, in newly diagnosed patients with type 2 diabetes.
Design and methods
In 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 β-cell function assessed by homeostasis model assessment, fasting proinsulin:insulin (PI/I), disposition index (DI) and acute insulin response (AIR).
At week 48, mean [95% confidence interval (CI)] HbA1c 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.
All three agents showed efficacy regarding glycaemic control and metabolic benefits; however, exenatide showed the greatest efficacy. β-cell function improved in all treatment groups; hence, early initiation of β-cell-protective therapy may halt the decline in β-cell function in type 2 diabetes.