A Randomized Controlled Trial on the Safety and Efficacy of Exenatide Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes

被引:58
作者
Fayfman, Maya [1 ]
Galindo, Rodolfo J. [1 ]
Rubin, Daniel J. [2 ]
Mize, Dara L. [3 ]
Anzola, Isabel [1 ]
Urrutia, Maria A. [1 ]
Ramos, Clementina [1 ]
Pasquel, Francisco J. [1 ]
Haw, J. Sonya [1 ]
Vellanki, Priyathama [1 ]
Wang, Heqiong [4 ]
Albury, Bonnie S. [1 ]
Weaver, Rita [3 ]
Cardona, Saumeth [1 ]
Umpierrez, Guillermo E. [1 ]
机构
[1] Emory Univ, Dept Med, Atlanta, GA 30322 USA
[2] Temple Univ, Dept Med, Philadelphia, PA 19122 USA
[3] Vanderbilt Univ, Sch Med, Nashville, TN 37212 USA
[4] Emory Univ, Rollins Sch Publ Hlth, Atlanta, GA 30322 USA
基金
美国国家卫生研究院;
关键词
ASSOCIATION CONSENSUS STATEMENT; INTENSIVE INSULIN THERAPY; GLUCAGON-LIKE PEPTIDE-1; CRITICALLY-ILL; INTRAVENOUS EXENATIDE; HOSPITALIZED-PATIENTS; GLYCEMIC CONTROL; GLUCOSE CONTROL; CLINICAL ENDOCRINOLOGISTS; AMERICAN ASSOCIATION;
D O I
10.2337/dc18-1760
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVE This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS A total of 150 patients with blood glucose (BG) between 140 and 400 mg/dL, treated at home with diet, oral agents, or insulin at a total daily dose <0.5 units/kg, were randomized to exenatide alone (5 mu g twice daily), exenatide plus basal insulin, or a basal-bolus insulin regimen. The primary end point was difference in mean daily BG concentration among groups. RESULTS Mean daily BG was similar between patients treated with exenatide plus basal and a basal-bolus regimen (154 +/- 39 vs. 166 +/- 40 mg/dL, P = 0.31), and exenatide plus basal resulted in lower daily BG than did exenatide alone (177 +/- 41 mg/dL, P = 0.02). Exenatide plus basal resulted in a higher proportion of BG levels in target range between 70 and 180 mg/dL compared with exenatide and basal-bolus (78% vs. 62% vs. 63%, respectively, P = 0.023). More patients in the exenatide and exenatide plus basal groups experienced nausea or vomiting than in the basal-bolus group (10% vs. 11% vs. 2%, P = 0.17), with three patients (6%) discontinued exenatide owing to adverse events. There were no differences in hypoglycemia <54 mg/dL (2% vs. 0% vs. 4%, P = 0.77) or length of stay (5 vs. 4 vs. 4 days, P = 0.23) among basal plus exenatide, exenatide, and basal-bolus groups. CONCLUSIONS The results of this pilot study indicate that exenatide alone or in combination with basal insulin is safe and effective for the management of hospitalized general medical and surgical patients with T2D.
引用
收藏
页码:450 / 456
页数:7
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