DURATION-5: Exenatide Once Weekly Resulted in Greater Improvements in Glycemic Control Compared with Exenatide Twice Daily in Patients with Type 2 Diabetes

被引：363

作者：

Blevins, Thomas ^{[1
]}

Pullman, John ^{[2
]}

Malloy, Jaret ^{[3
]}

Yan, Ping ^{[4
]}

Taylor, Kristin ^{[3
]}

Schulteis, Christine ^{[3
]}

Trautmann, Michael ^{[5
]}

Porter, Lisa ^{[3
]}

机构：

[1] Texas Diabet & Endocrinol, Austin, TX 78731 USA

[2] Mercury St Med, Dept Clin Res, Butte, MT 59701 USA

[3] Amylin Pharmaceut Inc, Med Dev, San Diego, CA 92121 USA

[4] Corp Analyt, San Diego, CA 92121 USA

[5] Eli Lilly & Co, Lilly Diabet, Indianapolis, IN 46285 USA

来源：

JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM | 2011年 / 96卷 / 05期

关键词：

OPEN-LABEL; INSULIN GLARGINE; TREATED PATIENTS; BODY-WEIGHT; EXENDIN-4; METFORMIN; GLUCOSE; SAFETY; SULFONYLUREA; LIRAGLUTIDE;

D O I：

10.1210/jc.2010-2081

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Context: We wanted to understand the effects of once-weekly vs. twice-daily glucagon-like peptide-1 receptor agonism for treatment of patients with type 2 diabetes. Objective: The objective of the study was to compare effects of exenatide once weekly (ExQW) and exenatide twice daily (ExBID) on glycemic control, body weight, and safety. Design: This was a 24-wk, randomized, open-label, comparator-controlled study. Setting: The study was conducted at 43 sites in the United States. Patients: The study population was 252 intent-to-treat patients with type 2 diabetes [baseline (mean +/- SD): glycosylated hemoglobin (HbA1c) 8.4 +/- 1.2%, fasting plasma glucose 171 +/- 47 mg/dl, weight 96 +/- 20 kg] that were drug naive (19%) or previously treated with one (47%) or multiple (35%) oral antidiabetic medications. Interventions: Interventions included ExQW 2 mg for 24 wk or ExBID 5 mu g for 4 wk followed by ExBID 10 mu g for 20 wk. Main Outcome Measure: The change in HbA1c from baseline to wk 24 was measured. Results: At 24 wk, ExQW produced significantly greater changes from baseline (least squares mean +/- SE) vs. ExBID in HbA1c (-1.6 +/- 0.1% vs. -0.9 +/- 0.1%; P < 0.0001) and fasting plasma glucose (-35 +/- 5 mg/dl vs. -12 +/- 5 mg/dl; P = 0.0008). Similar reductions in mean body weight from baseline to wk 24 were observed in both groups (-2.3 +/- 0.4 kg and -1.4 +/- 0.4 kg). Both treatments were generally well tolerated. Transient and predominantly mild to moderate nausea, the most frequent adverse event, was less common with ExQW (14%) than with ExBID (35%). Injection-site reactions were infrequent, but more common with ExQW. No major hypoglycemia occurred. Conclusions: Continuous glucagon-like peptide-1 receptor agonism with ExQW resulted in superior glycemic control, with less nausea, compared with ExBID in patients with type 2 diabetes. Both groups lost weight. (J Clin Endocrinol Metab 96: 1301-1310, 2011)

引用

页码：1301 / 1310

页数：10

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