Exploratory Trial of Intranasal Administration of Glucagon-Like Peptide-1 in Japanese Patients With Type 2 Diabetes
Exploratory Trial of Intranasal Administration of Glucagon-Like Peptide-1 in Japanese Patients With Type 2 Diabetes
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DOI：
10.2337/dc13-0690
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发表时间：
2014-06
期刊：
影响因子：
16.2
通讯作者：
H. Ueno;M. Mizuta;Tomomi Shiiya;Wakaba Tsuchimochi;K. Noma;N. Nakashima;Mitsuteru Fujihara;M. Nakazato
中科院分区：
文献类型：
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作者：
H. Ueno;M. Mizuta;Tomomi Shiiya;Wakaba Tsuchimochi;K. Noma;N. Nakashima;Mitsuteru Fujihara;M. Nakazato
目的本研究旨在评估我们新开发的鼻用胰高血糖素样肽-1（GLP-1）化合物和注射器的有效性和安全性。研究设计和方法26例2型糖尿病患者参加了这项双盲安慰剂对照研究。含1.2 mg人GLP-1（7-36）酰胺或安慰剂的鼻用化合物在每次进餐前即刻给药，持续2周。结果GLP-1血浆峰浓度为47.2pmol/L，Tmax为8.1min，GLP-1组胰岛素分泌早期恢复，胰高血糖素分泌早期受到抑制。GLP-1给药后，糖蛋白水平显著降低，1，5-脱水葡萄糖醇水平显著升高。使用鼻用GLP-1后未观察到明显的不良事件。结论新开发的鼻用GLP-1化合物可能是治疗2型糖尿病的潜在药物。药物的长期应用应在未来的试验中进行评估。
OBJECTIVE This study aimed to assess the efficacy and safety of our newly developed nasal glucagon-like peptide-1 (GLP-1) compound and injector. RESEARCH DESIGN AND METHODS Twenty-six patients with type 2 diabetes were enrolled in this double-blind placebo-controlled study. The nasal compound containing 1.2 mg of human GLP-1 (7–36) amide or placebo was administered immediately before every meal for 2 weeks. RESULTS The plasma peak concentration of active GLP-1 was 47.2 pmol/L, and its Tmax was 8.1 min. The early phase of insulin and glucagon secretion were recovered and suppressed, respectively, in the GLP-1 group. Glycoalbumin levels became significantly lower and 1,5-anhydroglucitol levels significantly higher after GLP-1 administration. No marked adverse events were observed after using nasal GLP-1. CONCLUSIONS The newly developed nasal GLP-1 compound may be a potential treatment for type 2 diabetes. The long-term application of the drug should be evaluated in future trials.