期刊论文详细信息
Journal of Diabetes Investigation
Efficacy and safety of once‐weekly exenatide after switching from twice‐daily exenatide in patients with type 2 diabetes
for the Twin‐exenatide Study Group1  Yoshifumi Saisho2  Hiroshi Itoh2  Junichiro Irie2  Shu Meguro2  Yuusuke Watanabe2  Jun Inaishi2  Tami Tsuchiya2  Rie Murakami2  Hironobu Sasaki2  Tatsuhiro Masaoka3  Kinsei Kou4  Yasuhiko Kanazawa5  Akira Yamauchi6  Mikiya Tokui7  Yoshiaki Okubo8  Takatoshi Imai9 
[1] ;Department of Internal Medicine Division of Endocrinology, Metabolism and Nephrology Keio University School of Medicine Tokyo Japan;Department of Internal Medicine Division of Gastroenterology and Hepatology Keio University School of Medicine Tokyo Japan;Hiratsuka City Hospital Kanagawa Japan;Kawasaki Municipal Ida Hospital Kanagawa Japan;Suruga Clinic Shizuoka Japan;Tokui Clinic Kanagawa Japan;Tokyo Dental College Ichikawa General Hospital Chiba Japan;Yokohama Municipal Citizen's Hospital Kanagawa Japan;
关键词: Glucagon‐like peptide‐1 receptor agonist;    Treatment satisfaction;    Type 2 diabetes;   
DOI  :  10.1111/jdi.13146
来源: DOAJ
【 摘 要 】

Abstract Aims/Introduction To evaluate the efficacy and safety of once‐weekly (q.w.) extended‐release exenatide after switching from twice‐daily (b.i.d.) exenatide in patients with type 2 diabetes. Materials and Methods This was an investigator‐initiated, prospective, single‐arm, multicenter study. Individuals with type 2 diabetes who had been treated with exenatide b.i.d. for at least 3 months were enrolled and switched to exenatide q.w. for 24 weeks. The primary end‐point was change in HbA1c at week 24 to test the glucose‐lowering effect of exenatide q.w. versus exenatide b.i.d. Results A total of 58 Japanese individuals with type 2 diabetes completed the study. Glycated hemoglobin was reduced by 0.2% at week 24 (7.2 ± 1.2% vs 7.0 ± 1.2% [56 ± 13 vs 53 ± 13 mmol/mol], 95% confidence interval −0.4 to −0.03%, P < 0.005 for non‐inferiority, P = 0.01 for superiority). Fasting plasma glucose was reduced by 12 mg/dL at week 24 (154 ± 46 vs 142 ± 46 mg/dL, P = 0.02). β‐Cell function assessed by homeostasis model assessment of β‐cell function and C‐peptide index was significantly improved at week 24. The incidence of self‐reported hypoglycemia was reduced, and treatment satisfaction assessed by the Diabetes Treatment Satisfaction Questionnaire and Diabetes Medication Satisfaction Questionnaire was improved at week 24, with no change in body weight. There was no serious adverse event related to the study drug. Conclusions Switching from exenatide b.i.d. to exenatide q.w. resulted in a reduction in glycated hemoglobin, fasting plasma glucose and the incidence of hypoglycemia, and improvement in β‐cell function and treatment satisfaction in patients with type 2 diabetes. These findings will be useful for selecting optimal treatment in individuals with type 2 diabetes.

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