Once-weekly exenatide versus once- or twice-daily insulin detemir: randomized, open-label, clinical trial of efficacy and safety in patients with type 2 diabetes treated with metformin alone or in combination with sulfonylureas.
Once-weekly exenatide versus once- or twice-daily insulin detemir: randomized, open-label, clinical trial of efficacy and safety in patients with type 2 diabetes treated with metformin alone or in combination with sulfonylureas.
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DOI：
10.2337/dc12-1333
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发表时间：
2013-05
期刊：
影响因子：
16.2
通讯作者：
Vora J
中科院分区：
文献类型：
--
作者：
Davies M;Heller S;Sreenan S;Sapin H;Adetunji O;Tahbaz A;Vora J
这项多中心、开放标签、平行组研究比较了艾塞那肽每周一次（EQW）与滴定地特胰岛素在二甲双胍（联合或不联合磺脲类药物）控制不佳的2型糖尿病患者中的疗效和安全性。患者随机接受EQW（2 mg）或地特米尔（每日一次或两次，滴定至空腹血糖≤5.5 mmol/L）治疗26周。主要结局是终点时A1 C ≤7.0%和体重减轻≥1.0 kg的患者比例，通过logistic回归分析。次要结果包括血糖控制、心血管危险因素以及安全性和耐受性。在216例患者（意向治疗人群）中，111例接受EQW，105例接受地特。总体而言，44.1%（95%CI，34.7-53.9）的EQW治疗患者与11.4%（6.0-19.1）的地特米尔治疗患者实现了主要结局（P < 0.0001）。EQW治疗导致A1 C（最小二乘均值± SE，−1.30 ± 0.08% vs. −0.88 ± 0.08%; P < 0.0001）和体重（−2.7 ± 0.3 kg vs. +0.8 ± 0.4 kg; P < 0.0001）的下降幅度显著大于地特米。EQW组胃肠道相关和注射部位相关不良事件的发生率高于地特米组。两组均未发生严重低血糖。EQW组5例（6%）患者和地特组6例（7%）患者发生轻度低血糖;仅1例事件发生时未伴随磺脲类药物（地特组）。EQW治疗导致达到目标A1 C和体重减轻的患者比例显著高于地特治疗，低血糖风险较低。这些结果表明，对于口服降糖药血糖控制不佳的2型糖尿病患者，EQW是地特胰岛素治疗的可行替代方案。
This multicenter, open-label, parallel-arm study compared the efficacy and safety of exenatide once weekly (EQW) with titrated insulin detemir in patients with type 2 diabetes inadequately controlled with metformin (with or without sulfonylureas). Patients were randomized to EQW (2 mg) or detemir (once or twice daily, titrated to achieve fasting plasma glucose ≤5.5 mmol/L) for 26 weeks. The primary outcome was proportion of patients achieving A1C ≤7.0% and weight loss ≥1.0 kg at end point, analyzed by means of logistic regression. Secondary outcomes included measures of glycemic control, cardiovascular risk factors, and safety and tolerability. Of 216 patients (intent-to-treat population), 111 received EQW and 105 received detemir. Overall, 44.1% (95% CI, 34.7–53.9) of EQW-treated patients compared with 11.4% (6.0–19.1) of detemir-treated patients achieved the primary outcome (P < 0.0001). Treatment with EQW resulted in significantly greater reductions than detemir in A1C (least-square mean ± SE, −1.30 ± 0.08% vs. −0.88 ± 0.08%; P < 0.0001) and weight (−2.7 ± 0.3 kg vs. +0.8 ± 0.4 kg; P < 0.0001). Gastrointestinal-related and injection site–related adverse events occurred more frequently with EQW than with detemir. There was no major hypoglycemia in either group. Five (6%) patients in the EQW group and six (7%) patients in the detemir group experienced minor hypoglycemia; only one event occurred without concomitant sulfonylureas (detemir group). Treatment with EQW resulted in a significantly greater proportion of patients achieving target A1C and weight loss than treatment with detemir, with a low risk of hypoglycemia. These results suggest that EQW is a viable alternative to insulin detemir treatment in patients with type 2 diabetes with inadequate glycemic control using oral antidiabetes drugs.
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影响因子：
39.2
作者：
Heine, RJ;Van Gaal, LF;Brodows, RG
通讯作者：
Brodows, RG
DOI：
10.1038/oby.2001.13
发表时间：
2001-02-01
期刊：
OBESITY RESEARCH
影响因子：
--
作者：
Kolotkin, RL;Crosby, RD;Williams, GR
通讯作者：
Williams, GR
影响因子：
4.2
作者：
Blevins, Thomas;Han, Jenny;Aronoff, Stephen
通讯作者：
Aronoff, Stephen
影响因子：
2.3
作者：
Hompesch, Marcus;Ocheltree, Scott M.;Jacober, Scott J.
通讯作者：
Jacober, Scott J.
影响因子：
3.2
作者：
Philis-Tsimikas, Athena;Charpentier, Guillaume;Thorsteinsson, Birger
通讯作者：
Thorsteinsson, Birger