更新于：2024-11-18
Vildagliptin/Metformin Hydrochloride
二甲双胍维格列汀
更新于：2024-11-18
概要
基本信息
药物类型 小分子化药 |
别名 Eucreas、Galvumet、Galvus Met + [18] |
作用机制 DPP-4抑制剂(二肽基肽酶IV抑制剂)、PRKAB1激活剂(腺苷酸活化蛋白激酶亚基β1激活剂) |
治疗领域 |
在研适应症 |
非在研适应症- |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2007-11-14), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C21H37ClN8O2 |
InChIKeyPQETUJCOOSLMAX-OGDHSBAZSA-N |
CAS号2446159-61-9 |
关联
26
项与 二甲双胍维格列汀 相关的临床试验A Bioequivalence Study of Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets in Healthy Thai Adult Volunteers Under Fed Condition.
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT and Reference Product (Galvus Met®) in Healthy Thai Volunteers Under Fed Conditions
二甲双胍维格列汀片（II）在中国健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究
100 项与 二甲双胍维格列汀 相关的临床结果
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100 项与 二甲双胍维格列汀 相关的转化医学
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100 项与 二甲双胍维格列汀 相关的专利（医药）
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6
项与 二甲双胍维格列汀 相关的文献（医药）2022-06-01Diabetes therapy : research, treatment and education of diabetes and related disorders
Bioequivalence Studies of New Generic Formulations of Vildagliptin and Fixed-Drug Combination of Vildagliptin and Metformin Versus Respective Originator Products in Healthy Volunteers
Article
作者: Klingberg, Ulrike ; Gaikwad, Sumedh ; Prathap, Vamshi Ramana ; Schnaars, Yvonne ; Vadla, Hari Kiran Chary ; Gottwald-Hostalek, Ulrike
INTRODUCTION:
Vildagliptin and metformin are two well-established oral antidiabetics with a complementary mechanism of action. Two new generic products, vildagliptin and its fixed-drug combination (FDC) with metformin, were tested for bioequivalence versus the approved originator reference products (Galvus® and Eucreas®).
METHODS:
Three randomized studies with two-treatment, two-period, two-sequence crossover design were conducted in healthy adults. One study evaluated vildagliptin 50 mg tablets as single dose under fasting conditions. Vildagliptin-metformin FDC tablet strengths of 50/850 mg and 50/1000 mg were evaluated in separate studies as single dose under fed conditions, given 30 min after a standardized high-fat, high-calorie breakfast following 10 h overnight fasting. Blood samples for analysis were collected until 24 h after dosing in each study period. Bioequivalence between test (T) and reference (R) products required 90% confidence interval (CIs) for the geometric least square (LS) mean T/R ratio to be within 80-125% for the pharmacokinetic parameters, maximum plasma concentration (Cmax), and area under the curve (AUC0-t).
RESULTS:
The 90% CIs of geometric LS means of T/R ratio for Cmax and AUC0-t with vildagliptin tablets of 50 mg were 92.22-103.94% and 99.00-102.66%, respectively; corresponding results with FDC tablets for 50/850 mg tablets were 94.81-115.41% and 95.28-106.00% for vildagliptin and 90.87-101.18% and 90.56-100.09% for metformin; for 50/1000 mg tablets Cmax and AUC0-t were 105.56-122.30% and 98.30-107.55%, respectively, for vildagliptin and 92.14-103.73% and 94.60-101.81%, respectively, for metformin. Other parameters such as AUC0-∞, time to maximum concentration (Tmax), and terminal half-life (t1/2) were comparable between test and reference products. Adverse events (AEs), mainly vomiting, were reported without relevant difference between test and reference products in each study. AEs were generally mild and transient. No severe or serious AEs occurred.
CONCLUSIONS:
The new generic drug products of vildagliptin and the FDCs of vildagliptin and metformin demonstrated bioequivalence to the approved originator products and are therefore expected to provide similar therapeutic effects.
2020-12-01Clinical nutrition ESPEN
Selenium cleome droserifolia nanoparticles (Se-CNPs) and it's ameliorative effects in experimentally induced diabetes mellitus
Article
作者: Omnia, M A ; Elharrif, Mohamed G ; Abou Zaid, Omayma A R ; Alaa, E A ; Abdel Maksoud, H A
Diabetes mellitus is a group of metabolic disorders with great challenge in its treatment due to its pathological complication. In recent decade, there is extensive use of applying nanotechnology to medicinal plants as a trend in diabetes treatment due to phytochemical constituents. The present study aimed to evaluate the hypoglycemic effect of selenium cleome droserifolia nanoparticles (Se-CNPs) and/or Galvus met® treatment on streptozotocin induced diabetes mellitus in male rats. Fifty male Wistar rats were divided equally into five groups: control group, control diabetic group, diabetic group treated with Se-CNPs, diabetic group treated with Galvus met® and diabetic group treated with Se-CNPs plus Galvus met®. Glucose and insulin levels, Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST), Total Cholesterol (TC), Triacylglycerols (TG), High Density Lipoprotein (HDL-c), Very Low Density Lipoprotein cholesterol (VLDL-c), Low Density Lipoprotein cholesterol (LDL-c) and (NEFAs), urea and creatinine were evaluated. Also, histopathological changes in pancreatic tissue were examined. The results showed significant elevation in serum glucose concentration, ALT and AST activities, TG, LDL-c, VLDL-c and Non Esterified Fatty Acids (NEFAs), urea and creatinine levels while a significant decrease in serum insulin and HDL-c concentration in untreated diabetic rats when compared with control. Meanwhile, daily administration of Se-CNPs and/or Galvus met® to diabetic rats showed significant amelioration of these parameters.
2014-04-01Drugs1区 · 医学
Vildagliptin: A Review of Its Use in Type 2 Diabetes Mellitus
1区 · 医学
Review
作者: Keating, Gillian M
The dipeptidyl peptidase-4 inhibitor vildagliptin (Galvus®) is approved for use as monotherapy and combination therapy in type 2 diabetes mellitus. A fixed-dose combination of vildagliptin/metformin (Eucreas®) is also available. This article reviews the clinical efficacy and tolerability of vildagliptin in the treatment of type 2 diabetes, as well as summarizing its pharmacological properties. Results of randomized controlled trials demonstrated that oral vildagliptin improved glycaemic control when administered as monotherapy, as dual therapy in combination with metformin, a sulfonylurea or a thiazolidinedione, as triple therapy in combination with metformin plus a sulfonylurea, and in combination with insulin with or without metformin. Improvements in glycaemic control were also seen with vildagliptin in elderly patients with type 2 diabetes and in patients with type 2 diabetes and moderate or severe renal impairment. Vildagliptin was generally well tolerated in patients with type 2 diabetes, was weight neutral and was associated with a low risk of hypoglycaemia, reflecting its glucose-dependent mechanism of action. Thus, oral vildagliptin is a useful option as monotherapy or as add-on therapy for patients with type 2 diabetes.
100 项与 二甲双胍维格列汀 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
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研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 2型糖尿病 | 欧盟 | 2007-11-14 | |
| 2型糖尿病 | 冰岛 | 2007-11-14 | |
| 2型糖尿病 | 列支敦士登 | 2007-11-14 | |
| 2型糖尿病 | 挪威 | 2007-11-14 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 40 | (Vildagliptin and Metformin) | 簾簾壓衊鑰範廠齋夢觸(鏇餘構選鏇積膚餘糧鏇) = 鹽餘夢醖夢獵鏇窪遞齋 繭糧積窪襯鏇顧廠積製 (夢範繭壓積鬱壓獵襯範, 窪醖築餘糧齋鹽襯夢遞 ~ 醖醖蓋壓窪簾顧齋鑰鹹) 更多 | - | 2017-07-11 | ||
(Glimepiride and Metformin) | 簾簾壓衊鑰範廠齋夢觸(鏇餘構選鏇積膚餘糧鏇) = 簾築繭製遞製憲選壓獵 繭糧積窪襯鏇顧廠積製 (夢範繭壓積鬱壓獵襯範, 鑰餘範鹹淵衊憲願獵膚 ~ 鏇繭糧襯憲鏇鬱憲膚網) 更多 | ||||||
临床3期 | 171 | Placebo (Placebo) | 網襯壓鬱製衊壓繭淵鹹(襯繭鏇襯製憲繭顧淵糧) = 網築願選齋衊製衊衊獵 淵蓋願窪願築蓋觸憲醖 (窪廠獵齋獵鹹淵網積積, 構壓艱範築齋繭夢積糧 ~ 範醖觸壓遞繭齋選構糧) 更多 | - | 2015-02-23 | ||
(LMF237 50/250 mg) | 鏇範製夢憲壓鏇餘淵醖(憲蓋顧範顧遞餘繭築憲) = 糧範鑰窪窪獵鑰觸繭憲 網壓夢鹽網醖簾積廠壓 (繭餘觸鑰醖繭遞範選齋, 醖選遞襯齋鑰醖鹽夢願 ~ 鹽齋窪獵窪艱顧鹹淵顧) 更多 |
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