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【drug-news】2型糖尿病治疗新药瞻望
Vildagliptin (50 mg twice daily) was compared to Rosiglitazone (8 mg once daily) in a 24 week study of subjects with T2DM, mean baseline HbA1c of 7.5-11% (mean 8.7%) who had received no anti-diabetic therapy for at least 3 months prior to screening. Near maximal reduction in HbA1c was achieved at week 12 with Vildagliptin and by week 16 with Rosiglitazone. The mean reduction in HbA1c from baseline was 1.1% and 1.3% for Vildagliptin and Rosiglitazone, respectively, which was judged to be non-inferior by prespecified criteria. Both drugs reduced fasting plasma glucose (1.3 mM vs. 2.3 mM for Vildagliptin vs. Rosiglitazone, respectively). Body weight did not change with Vildagliptin therapy but increased slightly in subjects receiving Rosiglitazone (1.9 kg difference between groups). Both drugs were well tolerated with similar adverse event profiles, however edema was more common with Rosiglitazone. See Comparison of Vildagliptin and Rosiglitazone Monotherapy in Patients With Type 2 Diabetes: A 24-week, double-blind, randomized trial. Diabetes Care. 2007 Feb;30(2):217-23
一项历经24个星期的2型糖尿病人的研究，服用Vildagliptin (50 mg 一天两次)与服用Rosiglitazone罗格列酮(8 mg一天一次)比较，他们参加研究前三个月，未服抗糖尿病药物，基础血红蛋白降低（7.5-11% (平均 8.7%)。 服Vildagliptin于第12周，服Rosiglitazone罗格列酮于第16周，降低的基础值，分别为1.1% 和1.3%， 按prespecified标准测定。 空腹血糖降低，分别为1.3 mM 对. 2.3 mM。体重，服Vildagliptin 没有改变，服Rosiglitazone罗格列酮体重轻度增加。药物耐受性和副作用，无大差别。不过Rosiglitazone罗格列酮多见水肿。 Vildagliptin Clinical Development Program
Vildagliptin的临床发展计划
An update on the Vildagliptin Phase 3 clinical trial program, including Abstracts presented at the 2006 IDF Meeting in Cape Town, was presented in a December 6 2006 该Press Release, which addressed data including one versus twice daily dosing, tolerability, weight gain, and islet dysfunction.
2006年12月国际糖尿病基金会IDF的南非开普敦会议发布新闻，修订Vildagliptin的第三阶段临床研究计划，资料包括，剂量，一天一次到一天两次。耐受性，体重增加和胰岛功能 Clinical Data for the Vildagliptin Phase 3 Program was presented in a series of presentations at the 2006 Meeting of the American Diabetes Association. In some studies, Vildagliptin was used at a dose of 50 mg twice daily; in other studies, the dose was 50 mg once daily. Vildagliptin was well tolerated with no major serious adverse event profile. The drug was studied as monotherapy alone, or when added on to metformin. Among the interesting findings, Vildagliptin therapy increased the levels of GLP-1 and GIP in patients with both type 1 and type 2 diabetes. Vildagliptin therapy also produced favorable effects on lipid profiles, including reduction of triglycerides, in several studies. Vildagliptin produced a stimulation of insulin secretion after an oral glucose load, and Vildagliptin also improved insulin sensitivity after 6 weeks of therapy in patients with T2DM; evidence for improvement in the acute insulin secretory response to glucose and improved disposition index was also detected in a small 12 week study using Vildagliptin 50 mg b.i.d. To review the data see ADA 2006 Vildagliptin data
2006年美国糖尿病协会提交的Vildagliptin第三阶段的研究计划资料，有的研究，Vildagliptin50 mg 一天两次，有的50 mg一天一次。Vildagliptin耐受性好，没有什么副作用。该药可以单独治疗，也可加用甲福明metformin。在有趣的发现中，在1型和2型糖尿病人中，用Vildagliptin治疗，他们的GLP-1胰高血糖素样肽1 和 GIP胰高血糖素样肽都增加。Vildagliptin治疗，对脂质也产生好效果，包括甘油三脂。在一些研究中，Vildagliptin在口服葡萄糖负荷后，刺激胰岛素分泌。一些2型糖尿病人经过6个星期的治疗，胰岛素敏感也得到改善。对葡萄糖的反应，胰岛素快速分泌就是改善的证据。改善的指标可以在一项用Vildagliptin治疗50 mg，一天两次的研究中查获。，
A Vildagliptin (Galvus) Phase 3 update was provided on January 19 2006. The Vildagliptin NDA filing in the United States was accepted on March 30 2006 as described in a Novartis Press Release A 4 week study of Vildagliptin (LAF237) 100 mg daily was carried out in subjects with diet-controlled Type 2 diabetes (BMI 27.3) fasting plasma glucose ~9.0 mmol/liter. LAF237 reduced fasting glucose by 0.70 mmol/liter, 4-h prandial glucose excursion by 1.45 mmol/liter and mean 24-h glucose by 0.93 mmol/liter, in association with an increase in baseline and postprandial active GLP-1. The glucagon response to breakfast was reduced by LAF237 whereas overall insulin levels were not altered. See Inhibition of dipeptidyl peptidase-4 reduces glycemia, sustains insulin levels, and reduces glucagon levels in type 2 diabetes. J Clin Endocrinol 。Metab. 2004 May;89(5):2078-84.
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作者:admin@医学,生命科学 2011-08-22 17:22
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