Delving into the Latest Updates on Vildagliptin/Metformin Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Eucreas, Galvumet, Galvus Met

+ [19]

Target

DPP-4 x PRKAB1

Mechanism

DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors), PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Novartis Pharma AG

Active Organization

Novartis Europharm Ltd.Accord Healthcare SLU

Taizhou Overseas Pharmaceuticals Co., Ltd.

+ [4]

Inactive Organization

Novartis AG

Drug Highest PhaseApproved

First Approval Date

EU (14 Nov 2007),

Diabetes Mellitus, Type 2

Regulation-

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Structure

Molecular FormulaC21H37ClN8O2

InChIKeyPQETUJCOOSLMAX-OGDHSBAZSA-N

CAS Registry2446159-61-9

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 14 days washout period between the doses.

Start Date05 Sep 2024

Sponsor / Collaborator

Bio-innova Co., Ltd

NCT06244407 / Not yet recruitingPhase 1

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

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions

Start Date23 May 2024

Sponsor / Collaborator

International Bio Research

CTR20240583 / CompletedNot Applicable

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

[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of metformin and vildagliptin tablets (II) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：以 Novartis Pharma Schweiz AG持证的二甲双胍维格列汀片（II）（规格：850 mg / 50 mg，商品名：Eucreas®）为参比制剂，以山东朗诺制药有限公司生产的二甲双胍维格列汀片（II）（规格：850 mg / 50 mg）为受试制剂，通过单中心、单次给药、随机、开放、两周期、双交叉设计的临床研究来评价两种制剂在空腹和餐后状态下的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to use the metformin vildagliptin tablets (II) (specification: 850 mg / 50 mg, trade name: Eucreas®) licensed by Novartis Pharma Schweiz AG as the reference preparation and the metformin vildagliptin tablets (II) (specification: 850 mg / 50 mg) produced by Shandong Langnuo Pharmaceutical Co., Ltd. as the test preparation. The two preparations are evaluated for their bioequivalence in the fasting and fed state through a single-center, single-dose, randomized, open, two-period, double-crossover clinical study. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date01 Mar 2024

Sponsor / Collaborator

Shandong Langnuo Pharmaceutical Co., Ltd.

100 Clinical Results associated with Vildagliptin/Metformin Hydrochloride

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100 Translational Medicine associated with Vildagliptin/Metformin Hydrochloride

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100 Patents (Medical) associated with Vildagliptin/Metformin Hydrochloride

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6

Literatures (Medical) associated with Vildagliptin/Metformin Hydrochloride

01 Jun 2022·Diabetes Therapy

Bioequivalence Studies of New Generic Formulations of Vildagliptin and Fixed-Drug Combination of Vildagliptin and Metformin Versus Respective Originator Products in Healthy Volunteers

Article

Author: Klingberg, Ulrike ; Prathap, Vamshi Ramana ; Schnaars, Yvonne ; Vadla, Hari Kiran Chary ; Gottwald-Hostalek, Ulrike ; Gaikwad, Sumedh

INTRODUCTIONVildagliptin 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®).METHODSThree 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 (C_max), and area under the curve (AUC_0-t).RESULTSThe 90% CIs of geometric LS means of T/R ratio for C_max and AUC_0-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 C_max and AUC_0-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 AUC_0-∞, time to maximum concentration (T_max), and terminal half-life (t_1/2) 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.CONCLUSIONSThe 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.

01 Dec 2020·Clinical Nutrition ESPEN

Selenium cleome droserifolia nanoparticles (Se-CNPs) and it's ameliorative effects in experimentally induced diabetes mellitus

Article

Author: Abdel Maksoud, H A ; Elharrif, Mohamed G ; Abou Zaid, Omayma A R ; Omnia, M A ; Alaa, E 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.

01 Apr 2014·DrugsQ1 · MEDICINE

Vildagliptin: A Review of Its Use in Type 2 Diabetes Mellitus

Q1 · MEDICINE

Review

Author: 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 Deals associated with Vildagliptin/Metformin Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10BD08	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NO	Novartis Europharm Ltd.	14 Nov 2007
Diabetes Mellitus, Type 2	EU	Novartis Europharm Ltd.	14 Nov 2007
Diabetes Mellitus, Type 2	IS	Novartis Europharm Ltd.	14 Nov 2007
Diabetes Mellitus, Type 2	LI	Novartis Europharm Ltd.	14 Nov 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 1	US	Novartis AG	06 Mar 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02007278 (GLOBE, CTgov)	Phase 4	Diabetes Mellitus, Noninsulin-Dependent, 2 \| Hypoglycemia	40	vildagliptin and metformin (combination) (Vildagliptin and Metformin)	vridcauezr(tzdptfjpce) = flwsdgdxre iysaftmdzt (blbejxcpbx, fosvdcxnya - fqhtobbopj) View more	-	11 Jul 2017
				Metformin+glimepiride (Glimepiride and Metformin)	vridcauezr(tzdptfjpce) = zcqogkgxoj iysaftmdzt (blbejxcpbx, xwnbuizudy - jxshalpifn) View more
NCT01811485 (CLMF237A1303, CTgov)	Phase 3	Diabetes Mellitus, Type 2	171	Placebo (Placebo)	xkdhaccesa(xyaqqlteaf) = hjaeadfkit yagdnzlqkq (jbitjiqyvz, bfkezvygjh - hthujyaler) View more	-	23 Feb 2015
				LMF237 50/250 mg (LMF237 50/250 mg)	glvivwabja(eayexbyjyq) = ccqdjyvcxd odhpucgifw (blelwmhqnr, yfqqhnjhsd - jwosbfyssl) View more