PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators), Potassium channel blockers, VGKCs blockers(Voltage-gated potassium channel blockers)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Novo Nordisk A/S

Active Organization

Recipharm Stockholm AB

Inactive Organization

Novo Nordisk A/SNovo Nordisk, Inc.

Drug Highest PhaseApproved

First Approval Date

US (23 Jun 2008),

Diabetes Mellitus, Type 2

Regulation-

Structure

Molecular FormulaC27H36N2O4

InChIKeyFAEKWTJYAYMJKF-QHCPKHFHSA-N

CAS Registry135062-02-1

View All Structures (2)

Clinical Trials associated with Metformin Hydrochloride/Repaglinide

CTR20170171 / Completed

瑞格列奈二甲双胍片采用开放、单剂量、双周期、随机、自身交叉试验设计在健康志愿者人体生物等效性研究

[Translation] Bioequivalence study of repaglinide and metformin tablets in healthy volunteers using an open, single-dose, two-period, randomized, self-crossover trial design

采用开放、单剂量、双周期、随机、自身交叉试验设计，评价健康志愿者单剂量餐后口服受试制剂瑞格列奈二甲双胍片 2mg/500mg（陕西白鹿制药股份有限公司生产）与参比制剂瑞格列奈二甲双胍片（商品名：PrandiMet）2mg/500mg（Recipharm Stockholm AB 生产）的生物利用度及生物等效性。

[Translation]

An open, single-dose, two-period, randomized, self-crossover trial design was used to evaluate the bioavailability and bioequivalence of a single-dose oral administration of the test preparation repaglinide metformin tablets 2mg/500mg (produced by Shaanxi Bailu Pharmaceutical Co., Ltd.) and the reference preparation repaglinide metformin tablets (trade name: PrandiMet) 2mg/500mg (produced by Recipharm Stockholm AB) in healthy volunteers.

Start Date26 Mar 2017

Sponsor / Collaborator

Shaanxi BAI LU Pharmaceutical Co. Ltd.

CTR20161004 / Completed

瑞格列奈二甲双胍片人体生物等效性研究

[Translation] Study on the bioequivalence of repaglinide and metformin tablets in healthy volunteers

本试验旨在研究由成都苑东生物制药股份有限公司研制、生产的瑞格列奈二甲双胍片（每片含瑞格列奈2mg/盐酸二甲双胍500mg）和诺和诺德（Novo Nordisk）公司生产的瑞格列奈二甲双胍片（每片含瑞格列奈2mg/盐酸二甲双胍500mg）的相对生物利用度，评价两种制剂是否生物等效，为临床替代用药提供依据。

[Translation]

This study aims to study the relative bioavailability of repaglinide metformin tablets (each tablet contains 2 mg repaglinide/500 mg metformin hydrochloride) developed and produced by Chengdu Yuandong Biopharmaceutical Co., Ltd. and repaglinide metformin tablets (each tablet contains 2 mg repaglinide/500 mg metformin hydrochloride) produced by Novo Nordisk, evaluate whether the two preparations are bioequivalent, and provide a basis for clinical alternative drug use.

Start Date09 Dec 2016

Sponsor / Collaborator

Chengdu Easton Biopharmaceuticals Co., Ltd.

CTR20161002 / Completed

瑞格列奈二甲双胍片人体生物等效性研究

[Translation] Study on the bioequivalence of repaglinide and metformin tablets in healthy volunteers

[Translation]

Start Date09 Dec 2016

Sponsor / Collaborator

Chengdu Easton Biopharmaceuticals Co., Ltd.

100 Clinical Results associated with Metformin Hydrochloride/Repaglinide

100 Translational Medicine associated with Metformin Hydrochloride/Repaglinide

100 Patents (Medical) associated with Metformin Hydrochloride/Repaglinide

Literatures (Medical) associated with Metformin Hydrochloride/Repaglinide

Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy

Repaglinide/metformin fixed-dose combination to improve glycemic control in patients with type 2 diabetes: an update

Article

Author: Moses, Robert G

Type 2 diabetes is a progressive disease associated with high levels of morbidity and mortality and for which there is both a large and growing prevalence worldwide. Lifestyle advice plus metformin is commonly recommended initially to manage hyperglycemia and to minimize the risk of vascular complications. However, additional agents are required when glycemic targets cannot be achieved or maintained due to the progressive nature of the disease. Repaglinide/metformin fixed-dose combination (FDC) therapy (PrandiMet(®); Novo Nordisk, Bagsværd, Denmark) has been approved for use in the USA. This FDC is a rational second-line therapy given the complementary mechanisms of action of the components. Repaglinide is a rapidly absorbed, short-acting insulin secretagogue targeting postprandial glucose excursions; metformin is an insulin sensitizer with a longer duration of action that principally regulates basal glucose levels. A pivotal, 26-week, randomized study with repaglinide/metformin FDC therapy has been conducted in patients experiencing suboptimal control with previous oral antidiabetes therapy. Repaglinide/metformin FDC improved glycemic control and weight neutrality without adverse effects on lipid profiles. There were no major hypoglycemic episodes and patients expressed greater satisfaction with repaglinide/metformin FDC than previous treatments. Repaglinide/metformin FDC is expected to be more convenient than individual tablets for patients taking repaglinide and metformin in loose combination, and it is expected to improve glycemic control in patients for whom meglitinide or metformin monotherapies provide inadequate control.

100 Deals associated with Metformin Hydrochloride/Repaglinide

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10BD14	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	CN	Recipharm Stockholm AB	01 Jun 2012

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus	Phase 1	CN	Novo Nordisk A/S	01 Aug 2009
Diabetes Mellitus, Type 2	Phase 1	US	Novo Nordisk, Inc.	23 Jun 2008

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